opioid induced constipation in subjects with chronic non-cancer pain MedDRA version: 14.1 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Resolor
Product Name: Resolor
Product Code: M0001
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PRUCALOPRIDE
CAS Number: 179474818
Current Sponsor code: M0001
Other descript
Sponsors
Shire-Movetis NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria to be assessed at screening: 1. Subject is a male or non-pregnant, non-breastfeeding female out-patient =18 years of age (no upper age limit). 2. Subject has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids; has been on a stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on a stable daily dose of opioids for at least 15 weeks after Visit 1. 3. Subject is suffering from OIC (i.e. secondary to chronic opioid use), which is defined as having an average of =2 SBM/week and one or more of the following symptoms that started after initiating opioids: a. Very hard (little balls) and/or hard stools at least a quarter of the stools. b. Sensation of incomplete evacuation following at least a quarter of the stools. c. Straining at defecation at least a quarter of the time. The above criteria are only applicable for SBMs, i.e. bowel movements not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. Subjects who never have SBMs are considered to be constipated and are eligible for the trial. 4. Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [Dulcolax® (bisacodyl)/ enemas]. Main inclusion criteria to be assessed at baseline (randomisation): 1. Subject has been taken a stable maintenance dose of opioids during the run-in period. 2. Subject is constipated, i.e. had an average of =2 SBM/week during the run-in period.* 3. Subject stopped his/her laxative treatment and did not use rescue mediation on more than 75% of days of the run-in period.* 4. Subject did not use disallowed medication during the run-in period. * Excluding the first 7 days for subjects using medication influencing bowel habit. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 459 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 51
Exclusion criteria
Exclusion criteria: 1. Constipation is thought to be drug-induced (except for opioids). 2. Disallowed medication is being used. 3. Subject was on chronic therapy for chronic constipation prior to the start of opioid therapy. 4. Subject is suffering from secondary causes of chronic constipation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from OIC.;Secondary Objective: To assess the safety and tolerability of prucalopride in subjects aged 18 years and older with chronic non-cancer pain, suffering from OIC. To document the plasma concentrations of prucalopride in subjects aged 18 years and older with chronic non-cancer pain, suffering from OIC.;Primary end point(s): The proportion (%) of subjects with an average weekly frequency of at least 3 SBM/week (i.e. a responder) over the 12-week treatment period. A minimum of 28 days with e-diary data has to be present for a valid derivation of the primary endpoint. If less e-diary data are present the subject will be considered a non-responder.;Timepoint(s) of evaluation of this end point: over the 12-week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: bowel movement and intake of bisacodyl over the 12-week treatment period questionnaires / evaluations at weeks 0, 4, 12;Secondary end point(s): -The proportion (%) of subjects with an increase of =1 (spontaneous complete) bowel movement [(SC)BM]/week over the entire treatment period. - Average number of (SC)BM/week and change from baseline. - Number of (SC)BM/week: descriptive statistics and distribution in categories: 0, (0;1), [1;2); [2;3), [3;?). - Consistency per (SC)BM: descriptive statistics of 5-point score - Straining per (SC)BM: descriptive statistics of 5-point score - Sensation of complete evacuation per (S)BM: % (S)BM with sensation of complete evacuation. - Average time to first (SC)BM after intake of the trial medication on Day 1 and on Day 29. - Average number of Dulcolax® (bisacodyl) tablets taken per week and the average number of days with laxatives per week. The following scales will be summarised by descriptive statistics and by tabulations of proportions of subjects with an increase of =1 point: - Subject’s global assessment of severity of constipation. - Subject’s global assessment on efficacy of treatment. - PAC-SYM total, subscale and individual item scores. - PAC-QOL total, subscale and individual item scores. | — |
Countries
Belgium, Bulgaria, Czech Republic, France, Germany, Hungary, Netherlands, Poland, Spain, United Kingdom
Contacts
Public ContactShire-Movetis Clinical Trials
Shire-Movetis NV
Outcome results
None listed