An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED, PARALLEL GROUP PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04383119 FOR THE TREATMENT OF PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00601484

Enrollment

Registered

2008-01-28

Start date

2008-03-17

Completion date

2009-04-15

Last updated

2021-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystitis, Interstitial

Keywords

Painful Bladder Syndrome, monoclonal antibody

Brief summary

The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.

Interventions

DRUGPlacebo

placebo IV, single dose

DRUGPF-04383119

PF-04383119 200 mcg/kg IV, single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female adults at least 18 years of age; * Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.

Exclusion criteria

* Less than 6 months since onset of interstitial cystitis symptoms; * History of recurrent urinary tract infections, or genitourinary cancer; * History of hepatitis B, C or human immunodeficiency virus (HIV); * Use of certain drugs given into the bladder up to 1 month prior to study entry.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Average Daily Pain Score at Week 6	Baseline, Week 6	Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category.

Secondary

Measure	Time frame	Description
Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point.
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity.
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity.
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.
Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.
Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.
Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.
Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.
Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet \[voluntary\] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.
Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet \[voluntary\] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.
Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain.
Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain.
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.
Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep? Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance.
Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep? Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline.
Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores of 7 days prior to each assessment time point. Participants answered the following question: Over the past 24 hours, how much pain did you experience during or after sexual activity? Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain.
Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores in the 7 days prior to each assessment time point. Participants answered the following question: Over the past 24 hours, how much pain did you experience during or after sexual activity? Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline.
Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions consisted of 4 ranked answers from 0-never to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturnal and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.
Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions each of 4 ranked answers from 0-never, to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Baseline, Week 2, 4, 6, 10, 16	The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6, 16	Participants were asked the following question: Compared to when you began this trial, how would you rate your interstitial cystitis symptoms now? Participants responded on a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved and 7 = markedly improved; where higher scores indicated improvement. Participants who responded as 6 (moderately improved) or 7 (markedly improved) were defined as treatment responders. Number of participants with response based on GRA scale for all scale categories were reported in this outcome measure.
Patient's Global Satisfaction Assessment	Week 6, 16	Participant global satisfaction was assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked the following question: Overall, how satisfied are you with the drug that you received since you entered this trial? Participant's response was rated on a 5-point scale where 1=extremely dissatisfied (dissatisfy), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied; where higher scores indicated more satisfaction. Number of participants with each response was reported in this outcome measure.
Patient's Global Preference Assessment at Weeks 6, and 16	Week 6, 16	Participant global preference was assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using study medication. Participant reported previous treatment under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery and no treatment. Participants' preference was assessed using following categories: definitely prefer current drug, slightly prefer current drug, no preference, definitely prefer prior treatment and slightly prefer prior treatment. Number of participants under each of the categories was reported in this outcome measure. For previous treatment, a single participant may be represented in more than 1 category.
Patient Willingness to Re-use Medicine Assessment	Week 6, 16	Participant willingness to re-use study medication was assessed using PRTI which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked the following question: In the future, would you be willing to use the same drug that you have received since you entered this trial for your interstitial cystitis? Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, and definitely would not want to re-use.
Percentage of Participants Who Use Rescue Medication	Baseline up to Week 16	In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any United States Food and Drug Administration (US FDA) approved commercial product of acetaminophen 500 milligram (mg) tablet/capsule could be taken as rescue medication.
Ratio of Number of Days Rescue Medication Used	Baseline up to Week 16	In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by days rescue medication was used relative to the total number of days participant was in the study.
Average Number of Doses Per Day of Rescue Medication Used	Baseline up to Week 16	In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by doses of rescue medication used relative to the total number of days participant was in the study.
Amount of Rescue Medication Taken Per Day	Baseline up to Week 16	In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by amount of rescue medication (in mg) relative to the total number of days participant was in the study.
Time to First Dose of Rescue Medication as a Proportion of Total Days in Study	Baseline up to Week 16	In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Time to first dose of rescue medication was defined as the time (in days) from the first dose of study drug to the time of first dose of rescue medication use. Results were normalized by days (time \[in days\] to first dose of rescue medication) relative to the total number of days participant was in the study and reported in terms of proportion of total days in study.
Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16	Plasma Total NGF levels were assayed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Urine NGF was not analyzed because no reliable assay method was available for assessing urine NGF.
Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16	HB-EGF urine concentration (in picogram per milliliter \[pg/mL\]) at specified time points is reported here.
Anti-Proliferative Factor (APF) Urine Concentration	Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16	APF activity was determined using 3 H-thymidine incorporation assay. The results were expressed as the percentage of inhibition of 3 H-thymidine incorporation in epithelial cells from urine specimens in the presence of anti proliferative factor.
Number of Participants With Clinically Significant Change From Baseline in Physical Examination	Baseline up to Week 16	Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system and any additional assessments necessary to establish baseline status. Clinically significant change in physical examination was based on investigator's discretion.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Baseline up to Week 16	Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Clinically significant change in vital signs was based on investigator's discretion.
Number of Participants With Clinically Significant Change From Baseline in Body Weight	Baseline up to Week 16	Clinically significant change in body weight was based on investigator's discretion.
Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination	Baseline up to Week 16	Neurological examination included the assessment of cranial nerve function, coordination, reflexes, mental state, motor function, proprioception, gait and station, and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation). Clinically significant change in neurologic examination was based on investigator's discretion.
Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	Baseline, Week 2, 4, 10, 16	Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point.
Post-void Residual (PVR) Volume	Baseline, Week 2, 6, 16	PVR volume is an objective assessment of the amount of urine (in milliliter) left in the bladder after normal urination and monitored whether the active treatment had an adverse effect on lower urinary tract voiding function. The PVR volume was assessed using trans-abdominal ultrasound (for example, bladder scanner) with the participant in a supine position immediately after voluntary urination.
Number of Participants With Laboratory Abnormalities	Baseline up to Week 16	Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: \<0.8\lower limit of normal (LLN); reticulocytes count (absolute or percent): \<0.5\LLN or greater than (\>) 1.5\upper limit of normal (ULN); Platelets: \<0.5\LLN or \>1.75\ULN; white blood cell count: \<0.6\LLN or \>1.5\ULN; neutrophils (absolute or percent): \<0.8\LLN or \>1.2\ULN; basophils (absolute or percent): \>1.2\ULN; lymphocytes (absolute or percent): \<0.8\LLN or \>1.2\ULN; monocytes (absolute or percent): \>1.2\ULN. Serum Chemistry parameters: sodium: \<0.95\LLN or \>1.05\ULN, potassium, chloride, bicarbonate, calcium: \<0.9\LLN or \>1.1\ULN; magnesium: \>1.1\ULN or \<0.9\LLN; BUN (blood urea nitrogen): \>1.3\ ULN, creatinine: \>1.3\ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : \>3.0\ULN ; total bilirubin: \>1.5\ULN; albumin: \<0.8\LLN or \>1.2\ULN and glucose: \<0.6\LLN or \>1.5\*ULN.
Number of Participants With Presence of Anti-Drug Antibody (ADA)	Day 1, Week 4, 6, 16	Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme-linked immunosorbent assay (ELISA).
Plasma Concentration of Tanezumab	0 hour (pre-dose), 1, 2 hours post-dose on Day 1; and at Week 2, 4, 6, 10, 16	—
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	Baseline up to Week 16	Clinically significant criteria for ECG abnormality: PR interval (maximum increase from Baseline of \>=25% \[only if Baseline value was greater than 200 millisecond\] or otherwise 50%), QRS complex (maximum increase from Baseline of \>=25% \[only if Baseline value was greater than 200 millisecond\] or otherwise 50%), QT interval, QT interval corrected using the Fridericia's formula (QTcF) (maximum increase from Baseline of \>= 30 to \<60; or \>=60), QT interval corrected using the Bazett's formula (QTcB) (maximum increase from Baseline of \>= 30 to \<60; or \>=60) and RR interval.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Tanezumab A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	34
Placebo A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16.	31
Total	65

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	1
Overall Study	Lack of Efficacy	0	2
Overall Study	Lost to Follow-up	4	3
Overall Study	Randomized, but not treated	0	1
Overall Study	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	Total	Tanezumab	Placebo
Age, Continuous	44.9 years STANDARD_DEVIATION 15.2	43.5 years STANDARD_DEVIATION 13.9	46.4 years STANDARD_DEVIATION 16.6
Sex: Female, Male Female	58 Participants	31 Participants	27 Participants
Sex: Female, Male Male	7 Participants	3 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	23 / 34	17 / 30
serious Total, serious adverse events	2 / 34	4 / 30

Outcome results

Primary

Change From Baseline in Average Daily Pain Score at Week 6

Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category.

Time frame: Baseline, Week 6

Population: Restricted Full Analysis Set(rFAS): All randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Average Daily Pain Score at Week 6	Baseline	6.4 units on a scale	Standard Deviation 1.39
Tanezumab	Change From Baseline in Average Daily Pain Score at Week 6	Change at Week 6	-2.3 units on a scale	Standard Deviation 1.88
Placebo	Change From Baseline in Average Daily Pain Score at Week 6	Baseline	5.9 units on a scale	Standard Deviation 1.15
Placebo	Change From Baseline in Average Daily Pain Score at Week 6	Change at Week 6	-1.1 units on a scale	Standard Deviation 1.49

Comparison: Analysis was based on analysis of covariance (ANCOVA) model with terms for treatment, age, gender, body mass index (BMI), baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.90% CI: [-2.203, -0.51]

Secondary

Amount of Rescue Medication Taken Per Day

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by amount of rescue medication (in mg) relative to the total number of days participant was in the study.

Time frame: Baseline up to Week 16

Population: rFAS population: All randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows.

Arm	Measure	Value (MEDIAN)
Tanezumab	Amount of Rescue Medication Taken Per Day	0.00 mg per day
Placebo	Amount of Rescue Medication Taken Per Day	0.00 mg per day

Secondary

Anti-Proliferative Factor (APF) Urine Concentration

APF activity was determined using 3 H-thymidine incorporation assay. The results were expressed as the percentage of inhibition of 3 H-thymidine incorporation in epithelial cells from urine specimens in the presence of anti proliferative factor.

Time frame: Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Anti-Proliferative Factor (APF) Urine Concentration	Week 2	157.66 percentage of inhibition	Standard Deviation 70.74
Tanezumab	Anti-Proliferative Factor (APF) Urine Concentration	Day 1 (pre-dose)	141.40 percentage of inhibition	Standard Deviation 43.33
Tanezumab	Anti-Proliferative Factor (APF) Urine Concentration	Week 4	146.25 percentage of inhibition	Standard Deviation 39.04
Tanezumab	Anti-Proliferative Factor (APF) Urine Concentration	Week 6	161.38 percentage of inhibition	Standard Deviation 54.52
Tanezumab	Anti-Proliferative Factor (APF) Urine Concentration	Week 10	144.58 percentage of inhibition	Standard Deviation 55.21
Tanezumab	Anti-Proliferative Factor (APF) Urine Concentration	Week 16	152.55 percentage of inhibition	Standard Deviation 56.72
Placebo	Anti-Proliferative Factor (APF) Urine Concentration	Week 10	162.45 percentage of inhibition	Standard Deviation 62.07
Placebo	Anti-Proliferative Factor (APF) Urine Concentration	Week 6	149.07 percentage of inhibition	Standard Deviation 32.81
Placebo	Anti-Proliferative Factor (APF) Urine Concentration	Day 1 (pre-dose)	157.87 percentage of inhibition	Standard Deviation 76.65
Placebo	Anti-Proliferative Factor (APF) Urine Concentration	Week 2	156.96 percentage of inhibition	Standard Deviation 54.68
Placebo	Anti-Proliferative Factor (APF) Urine Concentration	Week 16	163.02 percentage of inhibition	Standard Deviation 59.98
Placebo	Anti-Proliferative Factor (APF) Urine Concentration	Week 4	163.80 percentage of inhibition	Standard Deviation 72.75

Secondary

Average Number of Doses Per Day of Rescue Medication Used

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by doses of rescue medication used relative to the total number of days participant was in the study.

Time frame: Baseline up to Week 16

Arm	Measure	Value (MEDIAN)
Tanezumab	Average Number of Doses Per Day of Rescue Medication Used	0.00 doses per day
Placebo	Average Number of Doses Per Day of Rescue Medication Used	0.00 doses per day

Secondary

Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16

Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point.

Time frame: Baseline, Week 2, 4, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	Change at Week 2	-1.5 units on a scale	Standard Deviation 1.64
Tanezumab	Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	Change at Week 4	-2.1 units on a scale	Standard Deviation 2.04
Tanezumab	Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	Change at Week 10	-2.2 units on a scale	Standard Deviation 1.93
Tanezumab	Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	Change at Week 16	-1.9 units on a scale	Standard Deviation 1.92
Placebo	Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	Change at Week 16	-1.7 units on a scale	Standard Deviation 1.77
Placebo	Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	Change at Week 2	-0.9 units on a scale	Standard Deviation 1.15
Placebo	Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	Change at Week 10	-1.4 units on a scale	Standard Deviation 1.87
Placebo	Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	Change at Week 4	-1.0 units on a scale	Standard Deviation 1.44

Comparison: Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.90% CI: [-1.363, 0.011]

Comparison: Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.90% CI: [-1.969, -0.297]

Comparison: Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.90% CI: [-1.79, 0.09]

Comparison: Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.90% CI: [-1.356, 0.457]

Secondary

Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16

The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores of 7 days prior to each assessment time point. Participants answered the following question: Over the past 24 hours, how much pain did you experience during or after sexual activity? Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-0.7 units on a scale	Standard Deviation 0.99
Tanezumab	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-0.7 units on a scale	Standard Deviation 1.24
Tanezumab	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-0.7 units on a scale	Standard Deviation 1.4
Tanezumab	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	2.1 units on a scale	Standard Deviation 1.03
Tanezumab	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-0.9 units on a scale	Standard Deviation 0.95
Tanezumab	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-0.7 units on a scale	Standard Deviation 0.98
Placebo	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-0.0 units on a scale	Standard Deviation 0.88
Placebo	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	1.4 units on a scale	Standard Deviation 0.84
Placebo	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-0.0 units on a scale	Standard Deviation 0.51
Placebo	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-0.4 units on a scale	Standard Deviation 0.47
Placebo	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-0.6 units on a scale	Standard Deviation 0.54
Placebo	Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-0.2 units on a scale	Standard Deviation 0.5

Comparison: Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.90% CI: [-1.443, 0.156]

Secondary

Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16

Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep? Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	2.3 units on a scale	Standard Deviation 0.73
Tanezumab	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-0.5 units on a scale	Standard Deviation 0.64
Tanezumab	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-0.7 units on a scale	Standard Deviation 0.76
Tanezumab	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-0.7 units on a scale	Standard Deviation 0.73
Tanezumab	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-0.7 units on a scale	Standard Deviation 0.76
Tanezumab	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-0.5 units on a scale	Standard Deviation 0.68
Placebo	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-0.3 units on a scale	Standard Deviation 0.86
Placebo	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	2.1 units on a scale	Standard Deviation 0.78
Placebo	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-0.4 units on a scale	Standard Deviation 0.69
Placebo	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-0.3 units on a scale	Standard Deviation 0.51
Placebo	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-0.5 units on a scale	Standard Deviation 0.63
Placebo	Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-0.3 units on a scale	Standard Deviation 0.75

Secondary

Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16

Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 2	-1.4 units on a scale	Standard Deviation 1.69
Tanezumab	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Baseline	5.4 units on a scale	Standard Deviation 1.78
Tanezumab	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 4	-1.7 units on a scale	Standard Deviation 1.96
Tanezumab	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 6	-1.7 units on a scale	Standard Deviation 2.07
Tanezumab	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 10	-1.6 units on a scale	Standard Deviation 2.17
Tanezumab	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 16	-1.3 units on a scale	Standard Deviation 2.09
Placebo	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 10	-0.4 units on a scale	Standard Deviation 1.58
Placebo	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 6	-0.2 units on a scale	Standard Deviation 1.42
Placebo	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Baseline	4.7 units on a scale	Standard Deviation 1.18
Placebo	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 2	-0.5 units on a scale	Standard Deviation 1.13
Placebo	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 16	-0.5 units on a scale	Standard Deviation 1.6
Placebo	Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 4	-0.4 units on a scale	Standard Deviation 1.3

Secondary

Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16

Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet \[voluntary\] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Baseline	149.9 milliliter (mL)/micturition	Standard Deviation 64.65
Tanezumab	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 16	-1.4 milliliter (mL)/micturition	Standard Deviation 50.61
Tanezumab	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 2	5.4 milliliter (mL)/micturition	Standard Deviation 43.18
Tanezumab	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 4	2.0 milliliter (mL)/micturition	Standard Deviation 36.56
Tanezumab	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 6	-4.0 milliliter (mL)/micturition	Standard Deviation 45.3
Tanezumab	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 10	-7.4 milliliter (mL)/micturition	Standard Deviation 43.26
Placebo	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 6	-0.4 milliliter (mL)/micturition	Standard Deviation 46.31
Placebo	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 4	2.6 milliliter (mL)/micturition	Standard Deviation 49.9
Placebo	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 16	-5.6 milliliter (mL)/micturition	Standard Deviation 41.48
Placebo	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Baseline	172.2 milliliter (mL)/micturition	Standard Deviation 67.85
Placebo	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 10	-8.4 milliliter (mL)/micturition	Standard Deviation 43.07
Placebo	Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 2	1.4 milliliter (mL)/micturition	Standard Deviation 41.87

Secondary

Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	0.7 episodes per 24 hours	Standard Deviation 1.21
Tanezumab	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-1.4 episodes per 24 hours	Standard Deviation 3.05
Tanezumab	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-1.6 episodes per 24 hours	Standard Deviation 3.09
Tanezumab	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-1.5 episodes per 24 hours	Standard Deviation 2.99
Tanezumab	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-1.7 episodes per 24 hours	Standard Deviation 3
Tanezumab	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-1.6 episodes per 24 hours	Standard Deviation 3.28
Placebo	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-2.1 episodes per 24 hours	Standard Deviation 4.62
Placebo	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	1.0 episodes per 24 hours	Standard Deviation 1.98
Placebo	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-2.4 episodes per 24 hours	Standard Deviation 4.95
Placebo	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-2.0 episodes per 24 hours	Standard Deviation 4.23
Placebo	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-2.4 episodes per 24 hours	Standard Deviation 4.94
Placebo	Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-2.1 episodes per 24 hours	Standard Deviation 4.83

Secondary

Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16

The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-1.1 micturitions per 24 hours	Standard Deviation 1.84
Tanezumab	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-0.3 micturitions per 24 hours	Standard Deviation 3.78
Tanezumab	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	14.2 micturitions per 24 hours	Standard Deviation 3.81
Tanezumab	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-0.7 micturitions per 24 hours	Standard Deviation 3.99
Tanezumab	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-0.8 micturitions per 24 hours	Standard Deviation 2.23
Tanezumab	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-0.5 micturitions per 24 hours	Standard Deviation 2.42
Placebo	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-0.5 micturitions per 24 hours	Standard Deviation 2.85
Placebo	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	13.0 micturitions per 24 hours	Standard Deviation 4.54
Placebo	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-1.0 micturitions per 24 hours	Standard Deviation 2.54
Placebo	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-0.9 micturitions per 24 hours	Standard Deviation 3.18
Placebo	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-0.6 micturitions per 24 hours	Standard Deviation 3.08
Placebo	Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-0.8 micturitions per 24 hours	Standard Deviation 3.05

Secondary

Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16

The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Baseline	7.1 micturitions per night	Standard Deviation 5.37
Tanezumab	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 2	-1.5 micturitions per night	Standard Deviation 4.22
Tanezumab	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 4	-1.6 micturitions per night	Standard Deviation 4.72
Tanezumab	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 6	-1.3 micturitions per night	Standard Deviation 3.36
Tanezumab	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 10	-1.6 micturitions per night	Standard Deviation 4.45
Tanezumab	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 16	0.1 micturitions per night	Standard Deviation 4.31
Placebo	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 10	-1.5 micturitions per night	Standard Deviation 4.95
Placebo	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Baseline	5.8 micturitions per night	Standard Deviation 5.52
Placebo	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 6	-2.1 micturitions per night	Standard Deviation 4.78
Placebo	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 2	-0.6 micturitions per night	Standard Deviation 3.48
Placebo	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 16	-1.6 micturitions per night	Standard Deviation 5.82
Placebo	Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 4	-1.5 micturitions per night	Standard Deviation 4.99

Secondary

Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16

The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturnal and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-3.2 units on a scale	Standard Deviation 3.53
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-3.1 units on a scale	Standard Deviation 3.02
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-2.5 units on a scale	Standard Deviation 2.23
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Baseline	12.3 units on a scale	Standard Deviation 2.25
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-2.8 units on a scale	Standard Deviation 2.62
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-3.3 units on a scale	Standard Deviation 3.71
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-2.3 units on a scale	Standard Deviation 3.25
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Baseline	11.7 units on a scale	Standard Deviation 2.52
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-1.8 units on a scale	Standard Deviation 2.54
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-2.1 units on a scale	Standard Deviation 2.8
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-2.5 units on a scale	Standard Deviation 2.71
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-2.1 units on a scale	Standard Deviation 2.6

Secondary

Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16

The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-2.9 units on a scale	Standard Deviation 3.75
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Baseline	13.8 units on a scale	Standard Deviation 2.75
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-2.0 units on a scale	Standard Deviation 2.71
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-3.2 units on a scale	Standard Deviation 3.28
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-3.0 units on a scale	Standard Deviation 3.22
Tanezumab	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-2.8 units on a scale	Standard Deviation 2.98
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-2.2 units on a scale	Standard Deviation 2.76
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-2.1 units on a scale	Standard Deviation 2.52
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-1.9 units on a scale	Standard Deviation 2.77
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-1.2 units on a scale	Standard Deviation 3.3
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-2.1 units on a scale	Standard Deviation 3.45
Placebo	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Baseline	13.2 units on a scale	Standard Deviation 3.08

Secondary

Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16

The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions consisted of 4 ranked answers from 0-never to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-4.0 units on a scale	Standard Deviation 3.95
Tanezumab	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-5.0 units on a scale	Standard Deviation 5.51
Tanezumab	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Baseline	22.8 units on a scale	Standard Deviation 3.82
Tanezumab	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-4.2 units on a scale	Standard Deviation 4.87
Tanezumab	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-4.4 units on a scale	Standard Deviation 5.43
Tanezumab	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-4.3 units on a scale	Standard Deviation 5.81
Placebo	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-3.6 units on a scale	Standard Deviation 2.96
Placebo	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Baseline	21.1 units on a scale	Standard Deviation 3.91
Placebo	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-3.3 units on a scale	Standard Deviation 4.59
Placebo	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-3.0 units on a scale	Standard Deviation 4.06
Placebo	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-3.6 units on a scale	Standard Deviation 4.49
Placebo	Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-3.5 units on a scale	Standard Deviation 4.18

Secondary

Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	8.5 episodes per 24 hours	Standard Deviation 4.88
Tanezumab	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-1.7 episodes per 24 hours	Standard Deviation 3.49
Tanezumab	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-1.8 episodes per 24 hours	Standard Deviation 2.95
Tanezumab	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-1.9 episodes per 24 hours	Standard Deviation 4.74
Tanezumab	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-1.4 episodes per 24 hours	Standard Deviation 5.91
Tanezumab	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-2.1 episodes per 24 hours	Standard Deviation 4.84
Placebo	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-0.9 episodes per 24 hours	Standard Deviation 4.31
Placebo	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Baseline	8.7 episodes per 24 hours	Standard Deviation 6.75
Placebo	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-0.1 episodes per 24 hours	Standard Deviation 3.88
Placebo	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-0.4 episodes per 24 hours	Standard Deviation 2.97
Placebo	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-0.7 episodes per 24 hours	Standard Deviation 4.12
Placebo	Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	0.1 episodes per 24 hours	Standard Deviation 3.39

Secondary

Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration

HB-EGF urine concentration (in picogram per milliliter \[pg/mL\]) at specified time points is reported here.

Time frame: Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.~Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 4	123.59 pg/mL	Standard Deviation 73.19
Tanezumab	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 6	119.54 pg/mL	Standard Deviation 80.83
Tanezumab	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Day 1 (pre-dose)	108.70 pg/mL	Standard Deviation 71.15
Tanezumab	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 2	126.08 pg/mL	Standard Deviation 48.3
Tanezumab	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 10	100.94 pg/mL	Standard Deviation 60.87
Tanezumab	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 16	115.72 pg/mL	Standard Deviation 55.14
Placebo	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 10	115.39 pg/mL	Standard Deviation 65.66
Placebo	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 4	120.09 pg/mL	Standard Deviation 62.51
Placebo	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 2	109.48 pg/mL	Standard Deviation 61.93
Placebo	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 6	114.84 pg/mL	Standard Deviation 59.03
Placebo	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Week 16	128.60 pg/mL	Standard Deviation 75.62
Placebo	Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	Day 1 (pre-dose)	114.05 pg/mL	Standard Deviation 81.68

Secondary

Number of Participants With Clinically Significant Change From Baseline in Body Weight

Clinically significant change in body weight was based on investigator's discretion.

Time frame: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Body Weight	0 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Body Weight	0 Participants

Secondary

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)

Clinically significant criteria for ECG abnormality: PR interval (maximum increase from Baseline of \>=25% \[only if Baseline value was greater than 200 millisecond\] or otherwise 50%), QRS complex (maximum increase from Baseline of \>=25% \[only if Baseline value was greater than 200 millisecond\] or otherwise 50%), QT interval, QT interval corrected using the Fridericia's formula (QTcF) (maximum increase from Baseline of \>= 30 to \<60; or \>=60), QT interval corrected using the Bazett's formula (QTcB) (maximum increase from Baseline of \>= 30 to \<60; or \>=60) and RR interval.

Time frame: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	PR interval (maximum increase from Baseline of >=25 or 50%)	0 Participants
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QRS complex (maximum increase from Baseline of >=25 or 50%)	0 Participants
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QTcB (maximum increase from Baseline of >= 30 to <60)	4 Participants
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QTcB (maximum increase from Baseline of >=60)	0 Participants
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QTcF (maximum increase from Baseline of >= 30 to <60)	0 Participants
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QTcF (maximum increase from Baseline of >=60)	0 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QTcB (maximum increase from Baseline of >=60)	0 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	PR interval (maximum increase from Baseline of >=25 or 50%)	0 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QTcF (maximum increase from Baseline of >=60)	0 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QRS complex (maximum increase from Baseline of >=25 or 50%)	0 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QTcF (maximum increase from Baseline of >= 30 to <60)	0 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	QTcB (maximum increase from Baseline of >= 30 to <60)	2 Participants

Secondary

Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination

Neurological examination included the assessment of cranial nerve function, coordination, reflexes, mental state, motor function, proprioception, gait and station, and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation). Clinically significant change in neurologic examination was based on investigator's discretion.

Time frame: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination	3 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination	2 Participants

Secondary

Number of Participants With Clinically Significant Change From Baseline in Physical Examination

Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system and any additional assessments necessary to establish baseline status. Clinically significant change in physical examination was based on investigator's discretion.

Time frame: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Physical Examination	0 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Physical Examination	0 Participants

Secondary

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Clinically significant change in vital signs was based on investigator's discretion.

Time frame: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants
Placebo	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants

Secondary

Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16

Participants were asked the following question: Compared to when you began this trial, how would you rate your interstitial cystitis symptoms now? Participants responded on a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved and 7 = markedly improved; where higher scores indicated improvement. Participants who responded as 6 (moderately improved) or 7 (markedly improved) were defined as treatment responders. Number of participants with response based on GRA scale for all scale categories were reported in this outcome measure.

Time frame: Week 6, 16

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Slightly worse	2 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Moderately improved	5 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Moderately worse	2 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Markedly improved	5 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Markedly worse	0 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Moderately improved	5 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Slightly worse	1 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Moderately worse	1 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: No change	5 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Slightly improved	7 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Slightly improved	2 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: No change	5 Participants
Tanezumab	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Markedly improved	4 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: No change	6 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Slightly improved	5 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Moderately improved	2 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Markedly improved	0 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Markedly worse	1 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Slightly worse	3 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Moderately worse	0 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Moderately improved	1 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 6: Markedly improved	1 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Moderately worse	1 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Slightly worse	0 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: No change	5 Participants
Placebo	Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	Week 16: Slightly improved	5 Participants

Comparison: Week 6: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.90% CI: [1.709, 15.007]

Comparison: Week 16: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.90% CI: [0.756, 9.795]

Secondary

Number of Participants With Laboratory Abnormalities

Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: \<0.8\*lower limit of normal (LLN); reticulocytes count (absolute or percent): \<0.5\*LLN or greater than (\>) 1.5\*upper limit of normal (ULN); Platelets: \<0.5\*LLN or \>1.75\*ULN; white blood cell count: \<0.6\*LLN or \>1.5\*ULN; neutrophils (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; basophils (absolute or percent): \>1.2\*ULN; lymphocytes (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; monocytes (absolute or percent): \>1.2\*ULN. Serum Chemistry parameters: sodium: \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, bicarbonate, calcium: \<0.9\*LLN or \>1.1\*ULN; magnesium: \>1.1\*ULN or \<0.9\*LLN; BUN (blood urea nitrogen): \>1.3\* ULN, creatinine: \>1.3\*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : \>3.0\*ULN ; total bilirubin: \>1.5\*ULN; albumin: \<0.8\*LLN or \>1.2\*ULN and glucose: \<0.6\*LLN or \>1.5\*ULN.

Time frame: Baseline up to Week 16

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Number of Participants With Laboratory Abnormalities	23 Participants
Placebo	Number of Participants With Laboratory Abnormalities	18 Participants

Secondary

Number of Participants With Presence of Anti-Drug Antibody (ADA)

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme-linked immunosorbent assay (ELISA).

Time frame: Day 1, Week 4, 6, 16

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Number of Participants With Presence of Anti-Drug Antibody (ADA)	Day 1	0 Participants
Tanezumab	Number of Participants With Presence of Anti-Drug Antibody (ADA)	Week 4	0 Participants
Tanezumab	Number of Participants With Presence of Anti-Drug Antibody (ADA)	Week 6	0 Participants
Tanezumab	Number of Participants With Presence of Anti-Drug Antibody (ADA)	Week 16	0 Participants

Secondary

Patient's Global Preference Assessment at Weeks 6, and 16

Participant global preference was assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using study medication. Participant reported previous treatment under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery and no treatment. Participants' preference was assessed using following categories: definitely prefer current drug, slightly prefer current drug, no preference, definitely prefer prior treatment and slightly prefer prior treatment. Number of participants under each of the categories was reported in this outcome measure. For previous treatment, a single participant may be represented in more than 1 category.

Time frame: Week 6, 16

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Drug given into bladder	8 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: No preference	9 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Surgery	3 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: No Treatment	2 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week16: Definitely prefer current drug	6 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Slightly prefer current drug	5 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Slightly prefer prior treatment	1 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week16: Definitely prefer prior treatment	3 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: No preference	4 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Lifestyle interventions	10 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Physical therapies	6 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Toileting programs	1 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Drug taken by mouth	18 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Surgery	2 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: No Treatment	6 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Definitely prefer current drug	9 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Slightly prefer current drug	4 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Definitely prefer prior treatment	3 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Lifestyle interventions	10 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Physical therapies	5 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Toileting programs	2 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Drug given into bladder	7 Participants
Tanezumab	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Drug taken by mouth	15 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Toileting programs	0 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Drug given into bladder	4 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Surgery	2 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: No Treatment	2 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Definitely prefer current drug	2 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Lifestyle interventions	5 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: No preference	5 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Definitely prefer prior treatment	5 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Lifestyle interventions	5 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Drug taken by mouth	10 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Surgery	3 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Physical therapies	1 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: No Treatment	1 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Physical therapies	0 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week16: Definitely prefer current drug	1 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Toileting programs	0 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Slightly prefer current drug	4 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: No preference	3 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Slightly prefer current drug	4 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Slightly prefer prior treatment	0 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 6: Drug taken by mouth	10 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week16: Definitely prefer prior treatment	5 Participants
Placebo	Patient's Global Preference Assessment at Weeks 6, and 16	Week 16: Drug given into bladder	2 Participants

Secondary

Patient's Global Satisfaction Assessment

Participant global satisfaction was assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked the following question: Overall, how satisfied are you with the drug that you received since you entered this trial? Participant's response was rated on a 5-point scale where 1=extremely dissatisfied (dissatisfy), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied; where higher scores indicated more satisfaction. Number of participants with each response was reported in this outcome measure.

Time frame: Week 6, 16

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Patient's Global Satisfaction Assessment	Week 16: Extremely dissatisfied	1 Participants
Tanezumab	Patient's Global Satisfaction Assessment	Week 6: Satisfied	7 Participants
Tanezumab	Patient's Global Satisfaction Assessment	Week 6:Neither satisfied nor dissatisfied	7 Participants
Tanezumab	Patient's Global Satisfaction Assessment	Week 6: Dissatisfied	4 Participants
Tanezumab	Patient's Global Satisfaction Assessment	Week 6: Extremely satisfied	5 Participants
Tanezumab	Patient's Global Satisfaction Assessment	Week 6: Extremely dissatisfied	2 Participants
Tanezumab	Patient's Global Satisfaction Assessment	Week 16: Extremely satisfied	4 Participants
Tanezumab	Patient's Global Satisfaction Assessment	Week 16: Satisfied	7 Participants
Tanezumab	Patient's Global Satisfaction Assessment	Week16:Neither satisfied nor dissatisfied	5 Participants
Tanezumab	Patient's Global Satisfaction Assessment	Week 16: Dissatisfied	2 Participants
Placebo	Patient's Global Satisfaction Assessment	Week 16: Satisfied	6 Participants
Placebo	Patient's Global Satisfaction Assessment	Week 6: Extremely dissatisfied	2 Participants
Placebo	Patient's Global Satisfaction Assessment	Week 6: Satisfied	6 Participants
Placebo	Patient's Global Satisfaction Assessment	Week 16: Dissatisfied	2 Participants
Placebo	Patient's Global Satisfaction Assessment	Week 6:Neither satisfied nor dissatisfied	4 Participants
Placebo	Patient's Global Satisfaction Assessment	Week 16: Extremely satisfied	1 Participants
Placebo	Patient's Global Satisfaction Assessment	Week16:Neither satisfied nor dissatisfied	2 Participants
Placebo	Patient's Global Satisfaction Assessment	Week 16: Extremely dissatisfied	2 Participants
Placebo	Patient's Global Satisfaction Assessment	Week 6: Extremely satisfied	0 Participants
Placebo	Patient's Global Satisfaction Assessment	Week 6: Dissatisfied	4 Participants

Secondary

Patient Willingness to Re-use Medicine Assessment

Participant willingness to re-use study medication was assessed using PRTI which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked the following question: In the future, would you be willing to use the same drug that you have received since you entered this trial for your interstitial cystitis? Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, and definitely would not want to re-use.

Time frame: Week 6, 16

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 6: Might want to re-use	5 Participants
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 16: Not sure	2 Participants
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 16: Definitely want to re-use	7 Participants
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 16: Might not want to re-use	3 Participants
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 6: Not sure	9 Participants
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 16:Definitely not want re-use	2 Participants
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 16: Might want to re-use	5 Participants
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 6: Definitely want to re-use	9 Participants
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 6: Might not want to re-use	0 Participants
Tanezumab	Patient Willingness to Re-use Medicine Assessment	Week 6: Definitely not want to re-use	2 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 16: Might want to re-use	3 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 6: Might want to re-use	5 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 6: Not sure	3 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 6: Might not want to re-use	1 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 6: Definitely not want to re-use	4 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 16: Definitely want to re-use	4 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 6: Definitely want to re-use	3 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 16: Not sure	1 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 16: Might not want to re-use	2 Participants
Placebo	Patient Willingness to Re-use Medicine Assessment	Week 16:Definitely not want re-use	3 Participants

Secondary

Percentage of Participants Who Use Rescue Medication

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any United States Food and Drug Administration (US FDA) approved commercial product of acetaminophen 500 milligram (mg) tablet/capsule could be taken as rescue medication.

Time frame: Baseline up to Week 16

Population: rFAS population: all randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows.

Arm	Measure	Value (NUMBER)
Tanezumab	Percentage of Participants Who Use Rescue Medication	48.4 percentage of participants
Placebo	Percentage of Participants Who Use Rescue Medication	46.4 percentage of participants

Secondary

Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-33.3 percent change	Standard Deviation 34.52
Tanezumab	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-35.0 percent change	Standard Deviation 32.47
Tanezumab	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-36.3 percent change	Standard Deviation 29.1
Tanezumab	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-29.5 percent change	Standard Deviation 32.45
Tanezumab	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-23.2 percent change	Standard Deviation 26.41
Placebo	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-28.6 percent change	Standard Deviation 30.16
Placebo	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-15.9 percent change	Standard Deviation 19.64
Placebo	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-17.1 percent change	Standard Deviation 24.73
Placebo	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-18.3 percent change	Standard Deviation 26.88
Placebo	Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-23.5 percent change	Standard Deviation 30.66

Secondary

Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16

The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores in the 7 days prior to each assessment time point. Participants answered the following question: Over the past 24 hours, how much pain did you experience during or after sexual activity? Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-35.4 percent change	Standard Deviation 35.65
Tanezumab	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-19.4 percent change	Standard Deviation 83.01
Tanezumab	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-31.6 percent change	Standard Deviation 54.2
Tanezumab	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-43.5 percent change	Standard Deviation 38.21
Tanezumab	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-28.5 percent change	Standard Deviation 36.2
Placebo	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-19.4 percent change	Standard Deviation 75.54
Placebo	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-8.0 percent change	Standard Deviation 29.94
Placebo	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-38.6 percent change	Standard Deviation 43.33
Placebo	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-9.3 percent change	Standard Deviation 55.81
Placebo	Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-47.7 percent change	Standard Deviation 33.81

Secondary

Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16

Time frame: Baseline, Week 2, 4, 6, 10, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-32.0 percent change	Standard Deviation 38.58
Tanezumab	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-28.3 percent change	Standard Deviation 35.62
Tanezumab	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-33.8 percent change	Standard Deviation 35.41
Tanezumab	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-26.7 percent change	Standard Deviation 35.4
Tanezumab	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-23.7 percent change	Standard Deviation 29.81
Placebo	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-23.8 percent change	Standard Deviation 30.31
Placebo	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-11.6 percent change	Standard Deviation 28.42
Placebo	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-15.5 percent change	Standard Deviation 33.54
Placebo	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-17.4 percent change	Standard Deviation 29.31
Placebo	Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-11.2 percent change	Standard Deviation 52.83

Secondary

Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here 'number analyzed' signifies those participants who were evaluable for each specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 10	-25.9 percent change	Standard Deviation 44.02
Tanezumab	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 2	-26.2 percent change	Standard Deviation 31.24
Tanezumab	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 4	-32.5 percent change	Standard Deviation 37.82
Tanezumab	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 6	-29.9 percent change	Standard Deviation 37.29
Tanezumab	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 16	-23.0 percent change	Standard Deviation 41.99
Placebo	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 16	-10.7 percent change	Standard Deviation 38.13
Placebo	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 6	-5.2 percent change	Standard Deviation 37.85
Placebo	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 2	-13.1 percent change	Standard Deviation 26.06
Placebo	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 10	-7.0 percent change	Standard Deviation 37
Placebo	Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	Change at Week 4	-8.2 percent change	Standard Deviation 29.58

Secondary

Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 2	3.8 percent change	Standard Deviation 24.55
Tanezumab	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 10	-2.7 percent change	Standard Deviation 26.92
Tanezumab	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 6	-2.8 percent change	Standard Deviation 21.58
Tanezumab	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 16	-1.5 percent change	Standard Deviation 29.52
Tanezumab	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 4	0.3 percent change	Standard Deviation 21.29
Placebo	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 16	-5.3 percent change	Standard Deviation 23.03
Placebo	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 4	-0.8 percent change	Standard Deviation 28.54
Placebo	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 2	-0.1 percent change	Standard Deviation 22.07
Placebo	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 6	-2.3 percent change	Standard Deviation 29.04
Placebo	Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	Change at Week 10	-8.8 percent change	Standard Deviation 23.97

Secondary

Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16

The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'overall number of participants analyzed' = participants evaluable and had data available for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEDIAN)
Tanezumab	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-97.3 percent change
Tanezumab	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-100.0 percent change
Tanezumab	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-96.6 percent change
Tanezumab	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-82.5 percent change
Tanezumab	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-93.5 percent change
Placebo	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-81.7 percent change
Placebo	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-68.6 percent change
Placebo	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-70.3 percent change
Placebo	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-74.3 percent change
Placebo	Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-87.6 percent change

Comparison: Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.90% CI: [-27.56, 5.37]

Comparison: Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.90% CI: [-56.39, 0]

Comparison: Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.90% CI: [-40.44, 0]

Comparison: Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.90% CI: [-50.71, 0]

Comparison: Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.90% CI: [-36.87, 4.64]

Secondary

Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16

The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEDIAN)
Tanezumab	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-8.9 percent change
Tanezumab	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-14.9 percent change
Tanezumab	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-8.5 percent change
Tanezumab	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-5.0 percent change
Tanezumab	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-9.8 percent change
Placebo	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-10.2 percent change
Placebo	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-7.4 percent change
Placebo	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-0.1 percent change
Placebo	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-9.5 percent change
Placebo	Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-8.9 percent change

Secondary

Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16

The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Arm	Measure	Group	Value (MEDIAN)
Tanezumab	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 2	-8.8 percent change
Tanezumab	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 6	-17.7 percent change
Tanezumab	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 16	0.0 percent change
Tanezumab	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 4	-12.5 percent change
Tanezumab	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 10	-23.7 percent change
Placebo	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 16	-40.0 percent change
Placebo	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 2	-14.6 percent change
Placebo	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 4	-41.4 percent change
Placebo	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 6	-29.2 percent change
Placebo	Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	Change at Week 10	-25.0 percent change

Secondary

Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16

The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 4	-27.2 percent change	Standard Deviation 32.99
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 10	-21.2 percent change	Standard Deviation 21.68
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 2	-26.0 percent change	Standard Deviation 26.02
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 16	-24.6 percent change	Standard Deviation 25
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 6	-26.4 percent change	Standard Deviation 30.04
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 16	-18.3 percent change	Standard Deviation 26.07
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 2	-14.6 percent change	Standard Deviation 21.65
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 4	-18.3 percent change	Standard Deviation 22.88
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 6	-18.6 percent change	Standard Deviation 25.3
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	Change at Week 10	-23.0 percent change	Standard Deviation 25.21

Secondary

Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: RFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-21.0 percent change	Standard Deviation 21.07
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-14.1 percent change	Standard Deviation 18.01
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-23.2 percent change	Standard Deviation 24.62
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-20.5 percent change	Standard Deviation 28.12
Tanezumab	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-21.0 percent change	Standard Deviation 22
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-15.5 percent change	Standard Deviation 19.34
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-9.3 percent change	Standard Deviation 27.01
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-16.3 percent change	Standard Deviation 21.15
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-15.8 percent change	Standard Deviation 28.79
Placebo	Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-14.5 percent change	Standard Deviation 23.46

Secondary

Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16

The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions each of 4 ranked answers from 0-never, to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Population: rFAS population. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-17.0 percent change	Standard Deviation 16.23
Tanezumab	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-17.8 percent change	Standard Deviation 20.49
Tanezumab	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-21.4 percent change	Standard Deviation 23.14
Tanezumab	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-17.9 percent change	Standard Deviation 23.81
Tanezumab	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-18.9 percent change	Standard Deviation 24.33
Placebo	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 16	-18.3 percent change	Standard Deviation 14.98
Placebo	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 2	-15.6 percent change	Standard Deviation 21.67
Placebo	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 4	-14.9 percent change	Standard Deviation 19.52
Placebo	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 6	-18.5 percent change	Standard Deviation 22.38
Placebo	Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	Change at Week 10	-17.3 percent change	Standard Deviation 20.67

Secondary

Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16

The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.

Time frame: Baseline, Week 2, 4, 6, 10, 16

Arm	Measure	Group	Value (MEDIAN)
Tanezumab	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	-22.9 percent change
Tanezumab	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-30.4 percent change
Tanezumab	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-32.1 percent change
Tanezumab	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-19.5 percent change
Tanezumab	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-21.5 percent change
Placebo	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 16	-6.7 percent change
Placebo	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 10	-4.8 percent change
Placebo	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 4	0.8 percent change
Placebo	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 6	-1.6 percent change
Placebo	Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	Change at Week 2	-4.7 percent change

Comparison: Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.90% CI: [-27.32, 11.32]

Secondary

Plasma and Urine Total Nerve Growth Factor (NGF) Concentration

Plasma Total NGF levels were assayed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Urine NGF was not analyzed because no reliable assay method was available for assessing urine NGF.

Time frame: Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Day 1 (pre-dose)	16.47 picogram per milliliter (pg/mL)	Standard Deviation 7.38
Tanezumab	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 2	1943.45 picogram per milliliter (pg/mL)	Standard Deviation 579.77
Tanezumab	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 4	2654.76 picogram per milliliter (pg/mL)	Standard Deviation 913.4
Tanezumab	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 6	2542.80 picogram per milliliter (pg/mL)	Standard Deviation 926.78
Tanezumab	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 10	2396.09 picogram per milliliter (pg/mL)	Standard Deviation 861.74
Tanezumab	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 16	2202.04 picogram per milliliter (pg/mL)	Standard Deviation 1014.21
Placebo	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 10	13.63 picogram per milliliter (pg/mL)	Standard Deviation 6.69
Placebo	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Day 1 (pre-dose)	16.70 picogram per milliliter (pg/mL)	Standard Deviation 7.33
Placebo	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 6	16.49 picogram per milliliter (pg/mL)	Standard Deviation 8.64
Placebo	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 2	17.13 picogram per milliliter (pg/mL)	Standard Deviation 7.88
Placebo	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 16	15.47 picogram per milliliter (pg/mL)	Standard Deviation 7.89
Placebo	Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	Week 4	17.34 picogram per milliliter (pg/mL)	Standard Deviation 4.86

Secondary

Plasma Concentration of Tanezumab

Time frame: 0 hour (pre-dose), 1, 2 hours post-dose on Day 1; and at Week 2, 4, 6, 10, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Plasma Concentration of Tanezumab	Day 1 0 hour pre-dose	82.25 nanogram per milliliter (ng/mL)	Standard Deviation 435.8
Tanezumab	Plasma Concentration of Tanezumab	Day 1 1 hour post-dose	6070.81 nanogram per milliliter (ng/mL)	Standard Deviation 2521.35
Tanezumab	Plasma Concentration of Tanezumab	Day 1 2 hour post-dose	5520.63 nanogram per milliliter (ng/mL)	Standard Deviation 1558.81
Tanezumab	Plasma Concentration of Tanezumab	Week 2	1885.34 nanogram per milliliter (ng/mL)	Standard Deviation 403.93
Tanezumab	Plasma Concentration of Tanezumab	Week 4	1214.59 nanogram per milliliter (ng/mL)	Standard Deviation 410.16
Tanezumab	Plasma Concentration of Tanezumab	Week 6	888.70 nanogram per milliliter (ng/mL)	Standard Deviation 311.17
Tanezumab	Plasma Concentration of Tanezumab	Week 10	338.10 nanogram per milliliter (ng/mL)	Standard Deviation 144.84
Tanezumab	Plasma Concentration of Tanezumab	Week 16	104.07 nanogram per milliliter (ng/mL)	Standard Deviation 99.37

Secondary

Post-void Residual (PVR) Volume

PVR volume is an objective assessment of the amount of urine (in milliliter) left in the bladder after normal urination and monitored whether the active treatment had an adverse effect on lower urinary tract voiding function. The PVR volume was assessed using trans-abdominal ultrasound (for example, bladder scanner) with the participant in a supine position immediately after voluntary urination.

Time frame: Baseline, Week 2, 6, 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Number analyzed' = participants with available data for each specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab	Post-void Residual (PVR) Volume	Week 6	34.4 milliliter	Standard Deviation 35.26
Tanezumab	Post-void Residual (PVR) Volume	Week 16	49.4 milliliter	Standard Deviation 56.82
Tanezumab	Post-void Residual (PVR) Volume	Week 2	25.9 milliliter	Standard Deviation 34.24
Tanezumab	Post-void Residual (PVR) Volume	Baseline	28.8 milliliter	Standard Deviation 32.68
Placebo	Post-void Residual (PVR) Volume	Baseline	40.2 milliliter	Standard Deviation 48.25
Placebo	Post-void Residual (PVR) Volume	Week 6	38.6 milliliter	Standard Deviation 61.56
Placebo	Post-void Residual (PVR) Volume	Week 2	33.5 milliliter	Standard Deviation 48.62
Placebo	Post-void Residual (PVR) Volume	Week 16	21.8 milliliter	Standard Deviation 38.81

Secondary

Ratio of Number of Days Rescue Medication Used

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by days rescue medication was used relative to the total number of days participant was in the study.

Time frame: Baseline up to Week 16

Arm	Measure	Value (MEDIAN)
Tanezumab	Ratio of Number of Days Rescue Medication Used	0.00 ratio
Placebo	Ratio of Number of Days Rescue Medication Used	0.00 ratio

Secondary

Time to First Dose of Rescue Medication as a Proportion of Total Days in Study

In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Time to first dose of rescue medication was defined as the time (in days) from the first dose of study drug to the time of first dose of rescue medication use. Results were normalized by days (time \[in days\] to first dose of rescue medication) relative to the total number of days participant was in the study and reported in terms of proportion of total days in study.

Time frame: Baseline up to Week 16

Arm	Measure	Value (MEDIAN)
Tanezumab	Time to First Dose of Rescue Medication as a Proportion of Total Days in Study	0.00 proportion of days
Placebo	Time to First Dose of Rescue Medication as a Proportion of Total Days in Study	0.00 proportion of days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Average Daily Pain Score at Week 6

Amount of Rescue Medication Taken Per Day

Anti-Proliferative Factor (APF) Urine Concentration

Average Number of Doses Per Day of Rescue Medication Used

Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16

Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16

Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16

Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16

Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16

Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16

Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16

Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16

Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16

Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16

Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16

Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16

Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration

Number of Participants With Clinically Significant Change From Baseline in Body Weight

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)

Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination

Number of Participants With Clinically Significant Change From Baseline in Physical Examination

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16

Number of Participants With Laboratory Abnormalities

Number of Participants With Presence of Anti-Drug Antibody (ADA)

Patient's Global Preference Assessment at Weeks 6, and 16

Patient's Global Satisfaction Assessment

Patient Willingness to Re-use Medicine Assessment

Percentage of Participants Who Use Rescue Medication

Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16

Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16

Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16

Plasma and Urine Total Nerve Growth Factor (NGF) Concentration

Plasma Concentration of Tanezumab

Post-void Residual (PVR) Volume

Ratio of Number of Days Rescue Medication Used

Time to First Dose of Rescue Medication as a Proportion of Total Days in Study