Opioid Induced Constipation
Conditions
Keywords
Opioid Induced constipation,, constipation,, laxative,, bowel movement,, Movantik,, Naloxegol
Brief summary
The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.
Detailed description
This study is a prospective, randomized, open-label crossover study consisting of a 1-week washout period, a 2-week treatment period, another 1-week washout and a final 2-week treatment period. The study will assess the overall patient preference Movantik versus Polyethylene Glycol 3350 for the treatment of their opioid-induced constipation. This study will also evaluate the reasons for patient preference (only among subjects who indicate a preference), patient global impression of change, and change in bowel function over the treatment periods measured by Bowel Function Index. Patient's bowel movement diary will also be collected during the study.
Interventions
DRUGPolyethylene Glycol 3350
Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day. Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
DRUGMovantik
Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal. Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
Sponsors
QuintilesIMS, Inc.
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between the ages of ≥18 and \<85 years * Self-reported active symptoms of OIC (Opioid Induced Constipation) based on components of the Rome IV criteria at screening. Patients should have at least 2 of the following: * \<3 SBMs (Spontaneous Bowel Movements) per week * Straining \>25% of defecations * Sensation of incomplete evacuation \>25% of defecations * Lumpy or hard stools \>25% of defecations * Sensation of anorectal obstruction/blockage \>25% of defecations * Confirmed OIC by BFI (Bowel Function Index) ≥30 * Stable maintenance opioid regimen consisting of a total daily dose of at least 30 mg of oral morphine, or equivalent of 1 or more other opioid therapies * Willingness to stop all laxatives and other bowel regimens other than specified rescue medication
Exclusion criteria
* Pain related to cancer or has a history of cancer within 5 years * Current constipation or chronic constipation not caused by or related to use of opioids * History of rectal evacuation disorders, surgery or procedures that can potentially affect pelvic floor function; requirement of using manual maneuvers to facilitate a bowel movement * Evidence of significant GI structural abnormalities, acute or chronic GI conditions that could post risk to the patient or confound the study results * Recent surgery that may affect GI motility or increase risk for bowel obstruction or perforation * Severe hepatic impairment * Moderate or severe renal impairment * Condition that may affect the permeability of blood-brain barrier * Concomitantly using strong or moderate CYP3A4 inhibitors and strong CYP3A4 inducers * Any other significant and/or progressive medical, surgical, psychiatric, or mental health condition or any significant laboratory findings that could increase the risk of participation in the study or affect the interpretation of study data as determined by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment | From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study). | The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The 3 categories were formed by collapsing the 7-point rating scale to: 1. Prefer Movantik (including Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik), 2. No preference, and 3. Prefer PEG 3350 (including Strong preference for PEG 3350, Moderate preference for PEG 3350, and Slight preference for PEG 3350). The number of subjects in each category is presented for the total number of subjects in the Per-Protocol (PP) Set. |
| Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study). | The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The following categories were the possible responses: Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik, No preference, Slight preference for PEG 3350, Moderate preference for PEG 3350 and Strong preference for PEG 3350. Prefer Movantik included subjects in the categories Strong preference for Movantik, Moderate preference for Movantik and Slight preference for Movantik. Prefer PEG 3350 included subjects in the categories Strong preference for PEG 3350, Moderate preference for PEG 3350 and Slight preference for PEG 3350. Preference for Period 1 treatment and Preference for Period 2 treatment included subjects who preferred the first and second treatments respectively taken within a given treatment sequence. The number of subjects in each category is presented per treatment sequence for subjects in the PP Set. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2. | PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The scoring was as follows: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real difference; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms. Mean score results are presented for each treatment for Visits 3 and 5. |
| Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study). | In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the median score for each characteristic is presented for the overall PP Set according to which treatment was preferred. The assessment was only completed by subjects who indicated an overall preference. |
| Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36). | The BFI is a 3-item questionnaire administered by a study clinician to measure constipation from the subject's perspective (ease of defecation, feeling of complete evacuation, and personal judgment of constipation). For each item the subject was asked to rate their response on a scale from 0 to 100, where 0 indicates the best response (easy/no diffculty) and 100 the worst response (severe difficulty). The total BFI score was calculated as the mean of the 3 item scores. The mean change from baseline in BFI scores at Visits 3 and/or 5 are presented. |
| PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2. | PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The subjects selected one of the following PGIC items as their response: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real differences; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms. The number of subjects responding to each PGIC item at Visits 3 and/or 5 is presented for each treatment overall. |
| Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study). | In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the number of subjects in each characteristic category is presented for the overall PP Set according to which treatment was preferred. The assessment was only completed by subjects who indicated an overall preference. |
Countries
United States
Participant flow
Recruitment details
Study was performed in 53 sites in the United States. First subject first visit: 2 March 2017. Last subject completed: 23 August 2017. The entire planned duration of study participation was up to 7 weeks.
Pre-assignment details
350 subjects were screened and 74 subjects failed to meet the inclusion/exclusion criteria. 276 subjects were randomised to a treatment sequence.
Participants by arm
| Arm | Count |
|---|---|
| Movantik, Then PEG 3350 Subjects received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 2). | 132 |
| PEG 3350, Then Movantik Subjects received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 2). | 138 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 6 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Non-compliance with study medication | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | PEG 3350, Then Movantik | Total | Movantik, Then PEG 3350 |
|---|---|---|---|
| Age, Continuous | 56.9 Years STANDARD_DEVIATION 9.65 | 56.4 Years STANDARD_DEVIATION 9.52 | 55.9 Years STANDARD_DEVIATION 9.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 37 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 232 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 53 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 113 Participants | 214 Participants | 101 Participants |
| Sex: Female, Male Female | 89 Participants | 176 Participants | 87 Participants |
| Sex: Female, Male Male | 49 Participants | 94 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 271 | 0 / 268 |
| other Total, other adverse events | 66 / 271 | 46 / 268 |
| serious Total, serious adverse events | 3 / 271 | 1 / 268 |
Outcome results
Primary
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence
The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The following categories were the possible responses: Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik, No preference, Slight preference for PEG 3350, Moderate preference for PEG 3350 and Strong preference for PEG 3350. Prefer Movantik included subjects in the categories Strong preference for Movantik, Moderate preference for Movantik and Slight preference for Movantik. Prefer PEG 3350 included subjects in the categories Strong preference for PEG 3350, Moderate preference for PEG 3350 and Slight preference for PEG 3350. Preference for Period 1 treatment and Preference for Period 2 treatment included subjects who preferred the first and second treatments respectively taken within a given treatment sequence. The number of subjects in each category is presented per treatment sequence for subjects in the PP Set.
Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
Population: The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important important protocol deviation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | No preference | 2 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Strong preference for PEG 3350 | 37 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Slight preference for Movantik | 11 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Prefer Movantik | 62 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Slight preference for PEG 3350 | 9 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Prefer PEG 3350 | 61 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Moderate preference for Movantik | 14 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Preference for Period 1 treatment | 62 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Moderate preference for PEG 3350 | 15 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Preference for Period 2 treatment | 61 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Strong preference for Movantik | 37 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Preference for Period 2 treatment | 62 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Strong preference for Movantik | 38 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Moderate preference for Movantik | 17 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Slight preference for Movantik | 7 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | No preference | 2 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Slight preference for PEG 3350 | 8 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Moderate preference for PEG 3350 | 23 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Strong preference for PEG 3350 | 26 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Prefer Movantik | 62 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Prefer PEG 3350 | 57 Participants |
| PEG 3350, Then Movantik | Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence | Preference for Period 1 treatment | 57 Participants |
Comparison: Assessment of the difference in preference for the two treatments (Prefer Movantik, No Preference, Prefer PEG 3350) in subjects who completed the entire treatment sequence.p-value: 0.9239Prescott's test
Comparison: Assessment of the difference between preference for treatment in Period 1, preference for treatment in Period 2, no preferencep-value: 0.8874Prescott's test
Primary
Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment
The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The 3 categories were formed by collapsing the 7-point rating scale to: 1. Prefer Movantik (including Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik), 2. No preference, and 3. Prefer PEG 3350 (including Strong preference for PEG 3350, Moderate preference for PEG 3350, and Slight preference for PEG 3350). The number of subjects in each category is presented for the total number of subjects in the Per-Protocol (PP) Set.
Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
Population: The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment | Prefer Movantik | 124 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment | Prefer PEG 3350 | 118 Participants |
| Total (PP Set) | Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment | No preference | 4 Participants |
Secondary
Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms
The BFI is a 3-item questionnaire administered by a study clinician to measure constipation from the subject's perspective (ease of defecation, feeling of complete evacuation, and personal judgment of constipation). For each item the subject was asked to rate their response on a scale from 0 to 100, where 0 indicates the best response (easy/no diffculty) and 100 the worst response (severe difficulty). The total BFI score was calculated as the mean of the 3 item scores. The mean change from baseline in BFI scores at Visits 3 and/or 5 are presented.
Time frame: From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36).
Population: The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing BFI data at the end of at least one of the two week treatment periods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total (PP Set) | Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | -25.0 Score | Standard Deviation 31.64 |
| PEG 3350, Then Movantik | Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | -26.0 Score | Standard Deviation 28.82 |
Comparison: Analysis of Covariance (ANCOVA) model assessing treatment difference in BFI change from baseline at Visits 3/5 between Movantik and PEG 3350. Adjustments were performed for for baseline BFI score, treatment, period and sequence.95% CI: [-4.7, 3]
Secondary
Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms
PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The scoring was as follows: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real difference; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms. Mean score results are presented for each treatment for Visits 3 and 5.
Time frame: At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.
Population: The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing PGIC data at the end of at least one of the treatment periods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total (PP Set) | Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | 4.5 Score | Standard Deviation 1.83 |
| PEG 3350, Then Movantik | Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | 4.5 Score | Standard Deviation 1.83 |
Comparison: Analysis of variance (ANOVA) model assessing treatment difference in PGIC at Visits 3 and 5 between Movantik and PEG 3350 treatment. Adjustments were performed for treatment, period and sequence.95% CI: [-0.3, 0.3]
Secondary
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350
In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the number of subjects in each characteristic category is presented for the overall PP Set according to which treatment was preferred. The assessment was only completed by subjects who indicated an overall preference.
Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
Population: The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Efficacy: No Influence | 4 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Efficacy: Mildly Influenced | 18 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Efficacy: Moderately Influenced | 40 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Efficacy: Strongly Influenced | 61 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerability: No Influence | 14 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerability: Mildly Influenced | 16 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerability: Moderately Influenced | 30 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerability: Strongly Influenced | 63 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Convenience: No Influence | 5 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Convenience: Mildly Influenced | 6 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Convenience: Moderately Influenced | 26 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Convenience: Strongly Influenced | 86 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Quickly: No Influence | 15 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Quickly: Mildly Influenced | 25 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Quickly: Moderately Influenced | 35 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Quickly: Strongly Influenced | 48 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Predictably: No Influence | 11 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Predictably: Mildly Influenced | 21 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Predictably: Moderately Influenced | 36 Participants |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Predictably: Strongly Influenced | 55 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Predictably: Mildly Influenced | 15 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Efficacy: No Influence | 2 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Convenience: Moderately Influenced | 17 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Efficacy: Mildly Influenced | 20 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Quickly: Strongly Influenced | 32 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Efficacy: Moderately Influenced | 43 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Convenience: Strongly Influenced | 35 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Efficacy: Strongly Influenced | 52 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Predictably: Strongly Influenced | 42 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerability: No Influence | 15 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Quickly: No Influence | 14 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerability: Mildly Influenced | 11 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Predictably: No Influence | 12 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerability: Moderately Influenced | 32 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Quickly: Mildly Influenced | 30 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerability: Strongly Influenced | 59 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Predictably: Moderately Influenced | 48 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Convenience: No Influence | 39 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Works Quickly: Moderately Influenced | 41 Participants |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 | Convenience: Mildly Influenced | 26 Participants |
Secondary
Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350
In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the median score for each characteristic is presented for the overall PP Set according to which treatment was preferred. The assessment was only completed by subjects who indicated an overall preference.
Time frame: From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).
Population: The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerated better | 3.0 Score |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Worked quickly | 2.0 Score |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Was more convenient | 3.0 Score |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Worked predictably | 2.0 Score |
| Total (PP Set) | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Worked better to relieve my OIC | 2.0 Score |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Worked predictably | 2.0 Score |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Worked better to relieve my OIC | 2.0 Score |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Tolerated better | 3.0 Score |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Was more convenient | 1.0 Score |
| PEG 3350, Then Movantik | Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 | Worked quickly | 2.0 Score |
Secondary
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms
PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The subjects selected one of the following PGIC items as their response: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real differences; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms. The number of subjects responding to each PGIC item at Visits 3 and/or 5 is presented for each treatment overall.
Time frame: At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.
Population: The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing PGIC data at the end of at least one of the treatment periods.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total (PP Set) | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 3 | 21 Participants |
| Total (PP Set) | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 5 | 57 Participants |
| Total (PP Set) | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 2 | 30 Participants |
| Total (PP Set) | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 6 | 61 Participants |
| Total (PP Set) | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 4 | 38 Participants |
| Total (PP Set) | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 7 | 32 Participants |
| Total (PP Set) | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 1 | 23 Participants |
| PEG 3350, Then Movantik | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 7 | 28 Participants |
| PEG 3350, Then Movantik | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 1 | 27 Participants |
| PEG 3350, Then Movantik | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 2 | 27 Participants |
| PEG 3350, Then Movantik | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 3 | 20 Participants |
| PEG 3350, Then Movantik | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 4 | 33 Participants |
| PEG 3350, Then Movantik | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 5 | 66 Participants |
| PEG 3350, Then Movantik | PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms | PGIC Item 6 | 65 Participants |