Chronic Pain
Conditions
Keywords
Breakthrough Pain, Opioid-tolerant, Chronic Pain
Brief summary
Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid tolerant patients with chronic pain.
Interventions
FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain. The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets). For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician.
Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain. The maximum single dose would be 60 mg (4 capsules).
Sponsors
Cephalon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * The patient has chronic pain of at least 3 months duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia, chronic pancreatitis, osteoarthritis, rheumatoid arthritis, or cancer. Other chronic painful conditions may be evaluated for possible inclusion. * The patient is currently using at least one of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as ATC therapy for at least 7 days before administration of the first dose of study drug. * The patient is willing to provide written informed consent, including a written opioid agreement form, to participate in this study. * Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of birth control and agree to continued use of this method for the duration of the study. * Any patient with cancer should have a life expectancy of at least 3 months. * The patient reports an average PI score, over the 24 hours prior to screening, of 6 or less (0=no pain through 10=pain as bad as you can imagine) for their chronic pain. * The patient experiences, on average, at least 1 and less than 5 BTP episodes per day while taking ATC opioid therapy, and on average, the duration of each BTP episode is less than 4 hours during the screening period. * The patient currently uses opioid therapy for alleviation of BTP episodes, occurring at the location of the chronic pain, and achieves at least partial relief. * The patient must be willing and able to successfully self administer the study drug, comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol. Key
Exclusion criteria
* The patient has uncontrolled or rapidly escalating pain as determined by the investigator or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug. * The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse. * The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in either study drug. * The patient has a diagnosis of chronic headache or migraine as the primary painful condition with associated BTP. * The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids. * The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise the patient's safety or collected data. * The patient has suicidal ideation at screening or has a history of suicidal ideation within 1 year or history of suicide attempt within 2 years before screening, or a diagnosis of bipolar disorder or history of schizophrenia * The patient is expected to have surgery during the study that will impact the patient's chronic pain and/or BTP. * The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication. * The patient is pregnant or lactating. * The patient has participated in a previous study with FBT. * The patient has participated in a study involving an investigational drug in the prior 30 days. * The patient is currently using FBT or oral transmucosal fentanyl citrate for BTP. * The patient is currently using immediate-release oxycodone for BTP and is unwilling to undergo re-titration. * The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug. * The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that could, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data. * The patient is involved in active litigation in regard to the chronic pain currently being treated. * The patient has a positive UDS for an illicit drug or a medication not prescribed for him/her or which is not medically explainable (i.e., active metabolites). * The investigator feels that the patient is not suitable for the study for any reason (e.g., the patient's social history indicates an increased risk of drug diversion) * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15) | Immediately pre-dose and 15 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Difference (PID) at 10 Minutes Post-treatment | Immediately pre-dose and 10 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Pain Intensity Difference (PID) at 30 Minutes Post-treatment | Immediately pre-dose and 30 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Pain Intensity Difference (PID) at 45 Minutes Post-treatment | Immediately pre-dose and 45 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Pain Intensity Difference (PID) at 60 Minutes Post-treatment | Immediately pre-dose and 60 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment | Immediately pre-dose and 5 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. |
| Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment | Immediately before treatment and 10 minutes after treatment. | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period. |
| Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment | Baseline (immediately pre-dose) and 15 minutes after dosing | Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. |
| Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment | Pre-dose and 30 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. |
| Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment | Immediately pre-dose and 45 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. |
| Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment | Immediately pre-dose and 60 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. |
| Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30) | From 5 minutes after dosing through 30 minutes after dosing | PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60) | From 5 minutes after dosing through 60 minutes after dosing | PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug. SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Pain Relief (PR) Score at 5 Minutes Post-treatment | 5 minutes after treatment | The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). |
| Pain Relief Score at 10 Minutes Post-treatment | 10 minutes after treatment with study drug | The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). |
| Pain Relief Score at 15 Minutes Post-treatment | 15 minutes after treatment with study drug | The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). |
| Pain Relief Score at 30 Minutes Post-treatment | 30 minutes after treatment with study drug | The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). |
| Pain Relief Score at 45 Minutes Post-treatment | 45 minutes after treatment with study drug | The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). |
| Pain Relief Score at 60 Minutes Post-treatment | 60 minutes after treatment with study drug | The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). |
| Total Pain Relief at 60 Minutes (TOTPAR60) | From 5 minutes to 60 minutes after dosing | The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows: TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR) | From 5 minutes through 60 minutes after study drug treatment | The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase. |
| Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes | From time study drug was taken until 5 minutes after treatment | Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared. |
| Time to Any Pain Relief (APR) by Treatment <=10 Minutes | From study drug treatment until 10 minutes after treatment | Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared. |
| Time to Any Pain Relief (APR) by Treatment <=15 Minutes | From study drug administration to 15 minutes after treatment | Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared. |
| Time to Any Pain Relief (APR) by Treatment <=30 Minutes | Time of study drug administration till 30 minutes after treatment | Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared. |
| Time to Any Pain Relief (APR) by Treatment <=45 Minutes | Time of study drug treatment until 45 minutes after treatment | Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared. |
| Time to Any Pain Relief (APR) by Treatment <=60 Minutes | Time of study drug treatment until 60 minutes after treatment | Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared. |
| Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes | From time study drug was taken until 5 minutes after treatment | Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. |
| Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes | Time of study drug treatment until 10 minutes after treatment | Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared. |
| Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes | Time of study drug administration until 15 minutes after treatment | Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared. |
| Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes | Time of study drug administration until 30 minutes after treatment | Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared. |
| Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes | From study drug administration until 45 minutes after treatment | Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared. |
| Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes | Time of study drug administration until 60 minutes after treatment | Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared. |
| Use of Standard Rescue Medication | Throughout the double-blind treatment period | Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient's diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded. |
| Medication Performance Assessment 30 Minutes Post-treatment | 30 minutes post-treatment | The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded. |
| Medication Performance Assessment 60 Minutes Post-treatment | 60 minutes post-treatment | The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded. |
| Breakthrough Pain Preference Questionnaire | At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods. | The BTP preference questionnaire is a questionnaire used to measure patients' preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient's preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference. |
| Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment | One month after start of open-label treatment | The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period. |
| Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment | 2 months after start of open-label extension period | The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period. |
| Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment | 3 months after start of open-label extension period | The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period. |
| Pain Intensity Difference (PID) at 5 Minutes Post-treatment | Immediately pre-dose and 5 minutes after dosing | Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment | One month after start of open-label extension | The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician. The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period. |
| Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment | Two months after start of open-label extension period | The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician. The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination). |
| Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment | 3 months after start of open-label extension period | The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician. The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period. |
| Clinician Global Impression of Change (CGIC)Endpoint | End of open-label extension period | The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician. The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination). |
| Patient Global Impression of Change (PGIC) Endpoint | At conclusion of open-label extension period | The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period. |
Countries
United States
Participant flow
Recruitment details
Subjects with chronic pain who had been receiving opioid therapy for the previous 7 days and reported on average 1 to 5 breakthrough pain episodes per day were recruited from 50 different study sites throughout the United States beginning December 2008 and completing in November 2009.
Pre-assignment details
Prior to the double-blind treatment period, subjects participated in two titration periods to identify a successful and tolerated dose of FBT and immediate-release oxycodone. Subjects who did not titrate to a successful and tolerated dose were excluded from further participation in the study.
Participants by arm
| Arm | Count |
|---|---|
| Total Number of Patients | 213 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-blind Treatment Period 1 | Adverse Event | 1 | 1 |
| Double-blind Treatment Period 1 | Lost to Follow-up | 0 | 1 |
| Double-blind Treatment Period 1 | Protocol Violation | 0 | 2 |
| Double-blind Treatment Period 1 | Withdrawal by Subject | 0 | 1 |
| Double-blind Treatment Period 2 | Adverse Event | 1 | 0 |
| Double-blind Treatment Period 2 | Other | 1 | 0 |
| Double-blind Treatment Period 2 | Protocol Violation | 2 | 0 |
| Double-blind Treatment Period 2 | Withdrawal by Subject | 1 | 1 |
| Open-label Extension | Adverse Event | 1 | 2 |
| Open-label Extension | Lack of Efficacy | 3 | 0 |
| Open-label Extension | Non-compliance study medication | 4 | 0 |
| Open-label Extension | Non-compliance study procedures | 2 | 1 |
| Open-label Extension | Other | 1 | 0 |
| Open-label Extension | Protocol Violation | 1 | 2 |
| Open-label Extension | Withdrawal by Subject | 0 | 2 |
| Titration Period 1 | Adverse Event | 6 | 1 |
| Titration Period 1 | Lack of Efficacy | 9 | 7 |
| Titration Period 1 | Non-compliance to study medication | 4 | 1 |
| Titration Period 1 | Non-compliance to study procedures | 2 | 2 |
| Titration Period 1 | Protocol Violation | 4 | 3 |
| Titration Period 1 | Technical Difficulties | 0 | 1 |
| Titration Period 1 | Withdrawal by Subject | 2 | 2 |
| Titration Period 2 | Adverse Event | 2 | 3 |
| Titration Period 2 | Lack of Efficacy | 8 | 4 |
| Titration Period 2 | Lost to Follow-up | 1 | 0 |
| Titration Period 2 | Non-compliance with study procedures | 2 | 1 |
| Titration Period 2 | Protocol Violation | 3 | 2 |
Baseline characteristics
| Characteristic | Total Number of Patients |
|---|---|
| Age Continuous | 51.0 years STANDARD_DEVIATION 9.97 |
| Body Mass Index (BMI) | 30.1 kg/m^2 STANDARD_DEVIATION 7.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 191 Participants |
| Region of Enrollment United States | 213 participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 45 / 196 | 42 / 186 | 8 / 21 |
| serious Total, serious adverse events | 4 / 196 | 3 / 186 | 1 / 21 |
Outcome results
Primary
Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time frame: Immediately pre-dose and 15 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15) | 0.88 Units on scale | Standard Error 0.09 |
| Immediate-release Oxycodone (OXY) | Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15) | 0.76 Units on scale | Standard Error 0.09 |
Comparison: The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.p-value: 0.000495% CI: [0.06, 0.2]Mixed effects ANOVA crossover model
Secondary
Breakthrough Pain Preference Questionnaire
The BTP preference questionnaire is a questionnaire used to measure patients' preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient's preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.
Time frame: At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods.
Population: Double-blind safety analysis set: 143 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Breakthrough Pain Preference Questionnaire | Preferred FBT | 62 Participants |
| Fentanyl Buccal Tablet (FBT) | Breakthrough Pain Preference Questionnaire | Preferred Oxycodone | 46 Participants |
| Fentanyl Buccal Tablet (FBT) | Breakthrough Pain Preference Questionnaire | No Preference | 23 Participants |
| Fentanyl Buccal Tablet (FBT) | Breakthrough Pain Preference Questionnaire | Missing | 12 Participants |
Secondary
Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment
The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician. The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period.
Time frame: One month after start of open-label extension
Population: Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment | 1.4 Unit on a scale | Standard Deviation 0.79 |
| Immediate-release Oxycodone (OXY) | Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment | 0.6 Unit on a scale | Standard Deviation 0.91 |
Secondary
Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment
The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician. The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination).
Time frame: Two months after start of open-label extension period
Population: Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment | 1.4 Units on a scale | Standard Deviation 0.96 |
| Immediate-release Oxycodone (OXY) | Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment | 0.7 Units on a scale | Standard Deviation 0.88 |
Secondary
Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment
The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician. The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period.
Time frame: 3 months after start of open-label extension period
Population: Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment | 1.6 Units on a scale | Standard Deviation 0.81 |
| Immediate-release Oxycodone (OXY) | Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment | 0.7 Units on a scale | Standard Deviation 1.02 |
Secondary
Clinician Global Impression of Change (CGIC)Endpoint
The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician. The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination).
Time frame: End of open-label extension period
Population: Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Clinician Global Impression of Change (CGIC)Endpoint | 1.4 Units on a scale | Standard Deviation 1.01 |
| Immediate-release Oxycodone (OXY) | Clinician Global Impression of Change (CGIC)Endpoint | 0.7 Units on a scale | Standard Deviation 1.05 |
Secondary
Medication Performance Assessment 30 Minutes Post-treatment
The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded.
Time frame: 30 minutes post-treatment
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 30 Minutes Post-treatment | Excellent | 49 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 30 Minutes Post-treatment | Very Good | 125 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 30 Minutes Post-treatment | Good | 378 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 30 Minutes Post-treatment | Fair | 416 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 30 Minutes Post-treatment | Poor | 341 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 30 Minutes Post-treatment | No Response | 33 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 30 Minutes Post-treatment | Poor | 489 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 30 Minutes Post-treatment | Excellent | 16 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 30 Minutes Post-treatment | Fair | 391 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 30 Minutes Post-treatment | Very Good | 104 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 30 Minutes Post-treatment | No Response | 30 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 30 Minutes Post-treatment | Good | 304 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.p-value: <0.000195% CI: [1.4, 1.8]Generalized Estimating Equation
Secondary
Medication Performance Assessment 60 Minutes Post-treatment
The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded.
Time frame: 60 minutes post-treatment
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 60 Minutes Post-treatment | Fair | 181 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 60 Minutes Post-treatment | Excellent | 160 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 60 Minutes Post-treatment | Poor | 92 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 60 Minutes Post-treatment | Good | 508 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 60 Minutes Post-treatment | No Response | 30 Episodes |
| Fentanyl Buccal Tablet (FBT) | Medication Performance Assessment 60 Minutes Post-treatment | Very Good | 371 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 60 Minutes Post-treatment | No Response | 22 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 60 Minutes Post-treatment | Very Good | 313 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 60 Minutes Post-treatment | Good | 565 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 60 Minutes Post-treatment | Fair | 179 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 60 Minutes Post-treatment | Poor | 136 Episodes |
| Immediate-release Oxycodone (OXY) | Medication Performance Assessment 60 Minutes Post-treatment | Excellent | 119 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.p-value: <0.000195% CI: [1.2, 1.5]Generalized Estimating Equation
Secondary
Pain Intensity Difference (PID) at 10 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time frame: Immediately pre-dose and 10 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Intensity Difference (PID) at 10 Minutes Post-treatment | .35 Units on a scale | Standard Error 0.05 |
| Immediate-release Oxycodone (OXY) | Pain Intensity Difference (PID) at 10 Minutes Post-treatment | .29 Units on a scale | Standard Error 0.05 |
Comparison: The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.p-value: 0.010695% CI: [0.01, 0.11]ANOVA
Secondary
Pain Intensity Difference (PID) at 30 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time frame: Immediately pre-dose and 30 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Intensity Difference (PID) at 30 Minutes Post-treatment | 2.10 Units on a scale | Standard Error 0.12 |
| Immediate-release Oxycodone (OXY) | Pain Intensity Difference (PID) at 30 Minutes Post-treatment | 1.79 Units on a scale | Standard Error 0.12 |
Comparison: The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID30 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.p-value: <0.000195% CI: [0.21, 0.4]ANOVA
Secondary
Pain Intensity Difference (PID) at 45 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time frame: Immediately pre-dose and 45 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Intensity Difference (PID) at 45 Minutes Post-treatment | 3.13 Units on a scale | Standard Error 0.14 |
| Immediate-release Oxycodone (OXY) | Pain Intensity Difference (PID) at 45 Minutes Post-treatment | 2.85 Units on a scale | Standard Error 0.14 |
Comparison: The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.p-value: <0.000195% CI: [0.18, 0.37]ANOVA
Secondary
Pain Intensity Difference (PID) at 5 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time frame: Immediately pre-dose and 5 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Intensity Difference (PID) at 5 Minutes Post-treatment | .08 Units on a scale | Standard Error 0.02 |
| Immediate-release Oxycodone (OXY) | Pain Intensity Difference (PID) at 5 Minutes Post-treatment | .06 Units on a scale | Standard Error 0.02 |
Comparison: The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.p-value: 0.224295% CI: [-0.01, 0.05]ANOVA
Secondary
Pain Intensity Difference (PID) at 60 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time frame: Immediately pre-dose and 60 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Intensity Difference (PID) at 60 Minutes Post-treatment | 3.65 Units on a scale | Standard Error 0.15 |
| Immediate-release Oxycodone (OXY) | Pain Intensity Difference (PID) at 60 Minutes Post-treatment | 3.48 Units on a scale | Standard Error 0.15 |
Comparison: The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.p-value: 0.000295% CI: [0.08, 0.27]ANOVA
Secondary
Pain Relief (PR) Score at 5 Minutes Post-treatment
The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time frame: 5 minutes after treatment
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Relief (PR) Score at 5 Minutes Post-treatment | 0.11 Units on a scale | Standard Deviation 0.41 |
| Immediate-release Oxycodone (OXY) | Pain Relief (PR) Score at 5 Minutes Post-treatment | 0.10 Units on a scale | Standard Deviation 0.36 |
p-value: 0.5575Wilcoxon (Mann-Whitney)
Secondary
Pain Relief Score at 10 Minutes Post-treatment
The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time frame: 10 minutes after treatment with study drug
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Relief Score at 10 Minutes Post-treatment | 0.32 Units on a scale | Standard Deviation 0.61 |
| Immediate-release Oxycodone (OXY) | Pain Relief Score at 10 Minutes Post-treatment | 0.26 Units on a scale | Standard Deviation 0.49 |
p-value: 0.0981Wilcoxon (Mann-Whitney)
Secondary
Pain Relief Score at 15 Minutes Post-treatment
The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time frame: 15 minutes after treatment with study drug
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Relief Score at 15 Minutes Post-treatment | 0.68 Units on a scale | Standard Deviation 0.74 |
| Immediate-release Oxycodone (OXY) | Pain Relief Score at 15 Minutes Post-treatment | 0.56 Units on a scale | Standard Deviation 0.7 |
p-value: 0.0443Wilcoxon (Mann-Whitney)
Secondary
Pain Relief Score at 30 Minutes Post-treatment
The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time frame: 30 minutes after treatment with study drug
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Relief Score at 30 Minutes Post-treatment | 1.48 Units on a scale | Standard Deviation 0.83 |
| Immediate-release Oxycodone (OXY) | Pain Relief Score at 30 Minutes Post-treatment | 1.22 Units on a scale | Standard Deviation 0.81 |
p-value: 0.0004Wilcoxon (Mann-Whitney)
Secondary
Pain Relief Score at 45 Minutes Post-treatment
The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time frame: 45 minutes after treatment with study drug
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Relief Score at 45 Minutes Post-treatment | 2.14 Units on a scale | Standard Deviation 0.82 |
| Immediate-release Oxycodone (OXY) | Pain Relief Score at 45 Minutes Post-treatment | 1.90 Units on a scale | Standard Deviation 0.82 |
p-value: 0.0001Wilcoxon (Mann-Whitney)
Secondary
Pain Relief Score at 60 Minutes Post-treatment
The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time frame: 60 minutes after treatment with study drug
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Pain Relief Score at 60 Minutes Post-treatment | 2.44 Units on a scale | Standard Deviation 0.83 |
| Immediate-release Oxycodone (OXY) | Pain Relief Score at 60 Minutes Post-treatment | 2.27 Units on a scale | Standard Deviation 0.82 |
p-value: 0.0018Wilcoxon (Mann-Whitney)
Secondary
Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment
The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period.
Time frame: One month after start of open-label treatment
Population: Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment | 1.5 Unit on a scale | Standard Deviation 0.88 |
| Immediate-release Oxycodone (OXY) | Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment | 0.6 Unit on a scale | Standard Deviation 0.99 |
Secondary
Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment
The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period.
Time frame: 2 months after start of open-label extension period
Population: Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment | 1.5 Units on scale | Standard Deviation 0.99 |
| Immediate-release Oxycodone (OXY) | Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment | 0.8 Units on scale | Standard Deviation 0.99 |
Secondary
Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment
The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period.
Time frame: 3 months after start of open-label extension period
Population: Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment | 1.7 Units on scale | Standard Deviation 0.86 |
| Immediate-release Oxycodone (OXY) | Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment | 0.8 Units on scale | Standard Deviation 1.09 |
Secondary
Patient Global Impression of Change (PGIC) Endpoint
The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period.
Time frame: At conclusion of open-label extension period
Population: Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Patient Global Impression of Change (PGIC) Endpoint | 1.5 Units on a scale | Standard Deviation 1.02 |
| Immediate-release Oxycodone (OXY) | Patient Global Impression of Change (PGIC) Endpoint | 0.9 Units on a scale | Standard Deviation 1.09 |
Secondary
Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period.
Time frame: Immediately before treatment and 10 minutes after treatment.
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment | 4.83 Percentage change | Standard Deviation 11.21 |
| Immediate-release Oxycodone (OXY) | Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment | 3.89 Percentage change | Standard Deviation 8.3 |
Secondary
Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment
Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time frame: Baseline (immediately pre-dose) and 15 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment | 12.38 Percentage change | Standard Deviation 17.08 |
| Immediate-release Oxycodone (OXY) | Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment | 10.38 Percentage change | Standard Deviation 15.43 |
Secondary
Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time frame: Pre-dose and 30 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment | 29.72 Percentage change | Standard Deviation 21.3 |
| Immediate-release Oxycodone (OXY) | Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment | 25.03 Percentage change | Standard Deviation 20.42 |
Secondary
Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time frame: Immediately pre-dose and 45 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment | 44.84 Percentage change | Standard Deviation 23.36 |
| Immediate-release Oxycodone (OXY) | Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment | 40.49 Percentage change | Standard Deviation 22.68 |
Secondary
Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time frame: Immediately pre-dose and 5 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment | 1.01 Percentage change | Standard Deviation 4.5 |
| Immediate-release Oxycodone (OXY) | Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment | 0.73 Percentage change | Standard Deviation 3.02 |
Secondary
Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time frame: Immediately pre-dose and 60 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment | 52.61 Percentage change | Standard Deviation 24.33 |
| Immediate-release Oxycodone (OXY) | Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment | 49.47 Percentage change | Standard Deviation 24.19 |
Secondary
Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)
The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.
Time frame: From 5 minutes through 60 minutes after study drug treatment
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR) | 40.11 Percentage change | Standard Deviation 16.32 |
| Immediate-release Oxycodone (OXY) | Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR) | 35.59 Percentage change | Standard Deviation 15.78 |
Secondary
Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)
PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time frame: From 5 minutes after dosing through 30 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30) | 2.54 Units on a scale | Standard Error 0.17 |
| Immediate-release Oxycodone (OXY) | Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30) | 2.16 Units on a scale | Standard Error 0.17 |
p-value: <0.000195% CI: [0.25, 0.5]ANOVA
Secondary
Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)
PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug. SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time frame: From 5 minutes after dosing through 60 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60) | 9.32 Units on a scale | Standard Error 0.44 |
| Immediate-release Oxycodone (OXY) | Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60) | 8.50 Units on a scale | Standard Error 0.44 |
p-value: <0.000195% CI: [0.55, 1.1]ANOVA
Secondary
Time to Any Pain Relief (APR) by Treatment <=10 Minutes
Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared.
Time frame: From study drug treatment until 10 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Any Pain Relief (APR) by Treatment <=10 Minutes | 226 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Any Pain Relief (APR) by Treatment <=10 Minutes | 219 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.654595% CI: [0.8, 1.4]Generalized Estimating Equation
Secondary
Time to Any Pain Relief (APR) by Treatment <=15 Minutes
Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared.
Time frame: From study drug administration to 15 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Any Pain Relief (APR) by Treatment <=15 Minutes | 515 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Any Pain Relief (APR) by Treatment <=15 Minutes | 451 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.040795% CI: [1, 1.6]Generalized Estimating Equation
Secondary
Time to Any Pain Relief (APR) by Treatment <=30 Minutes
Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared.
Time frame: Time of study drug administration till 30 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Any Pain Relief (APR) by Treatment <=30 Minutes | 1004 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Any Pain Relief (APR) by Treatment <=30 Minutes | 877 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.000795% CI: [1.2, 2]Generalized Estimating Equation
Secondary
Time to Any Pain Relief (APR) by Treatment <=45 Minutes
Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared.
Time frame: Time of study drug treatment until 45 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Any Pain Relief (APR) by Treatment <=45 Minutes | 1217 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Any Pain Relief (APR) by Treatment <=45 Minutes | 1150 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.037295% CI: [1, 2.4]Generalized Estimating Equation
Secondary
Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes
Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared.
Time frame: From time study drug was taken until 5 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes | 55 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes | 50 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.701295% CI: [0.6, 2.3]Generalized Estimating Equation
Secondary
Time to Any Pain Relief (APR) by Treatment <=60 Minutes
Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared.
Time frame: Time of study drug treatment until 60 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Any Pain Relief (APR) by Treatment <=60 Minutes | 1271 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Any Pain Relief (APR) by Treatment <=60 Minutes | 1239 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.309995% CI: [0.7, 2.5]Generalized Estimating Equation
Secondary
Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes
Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared.
Time frame: Time of study drug treatment until 10 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes | 88 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes | 91 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.956795% CI: [0.6, 1.6]Generalized Estimating Equation
Secondary
Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes
Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared.
Time frame: Time of study drug administration until 15 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes | 230 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes | 212 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.425395% CI: [0.8, 1.6]Generalized Estimating Equation
Secondary
Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes
Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared.
Time frame: Time of study drug administration until 30 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes | 613 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes | 503 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.003895% CI: [1.1, 1.8]Generalized Estimating Equation
Secondary
Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes
Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared.
Time frame: From study drug administration until 45 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes | 983 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes | 864 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.001295% CI: [1.2, 1.9]Generalized Estimating Equation
Secondary
Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes
Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared.
Time frame: From time study drug was taken until 5 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes | 21 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes | 26 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.577795% CI: [0.5, 1.5]Generalized Estimating Equation
Secondary
Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes
Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared.
Time frame: Time of study drug administration until 60 minutes after treatment
Population: Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes | 1139 Episodes |
| Immediate-release Oxycodone (OXY) | Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes | 1047 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.007495% CI: [1.1, 2.2]Generalized Estimating Equation
Secondary
Total Pain Relief at 60 Minutes (TOTPAR60)
The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows: TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time frame: From 5 minutes to 60 minutes after dosing
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Total Pain Relief at 60 Minutes (TOTPAR60) | 6.43 units on a scale | Standard Error 0.2 |
| Immediate-release Oxycodone (OXY) | Total Pain Relief at 60 Minutes (TOTPAR60) | 5.70 units on a scale | Standard Error 0.2 |
p-value: <0.000195% CI: [0.58, 0.9]ANOVA
Secondary
Use of Standard Rescue Medication
Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient's diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.
Time frame: Throughout the double-blind treatment period
Population: Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl Buccal Tablet (FBT) | Use of Standard Rescue Medication | 39 Episodes |
| Immediate-release Oxycodone (OXY) | Use of Standard Rescue Medication | 41 Episodes |
Comparison: Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.p-value: 0.844495% CI: [0.6, 1.9]Generalized Estimating Equation