Chronic constipation MedDRA version: 14.1 Level: LLT Classification code 10063582 Term: Constipation chronic System Organ Class: 100000004856
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
Concentration
Sponsors
Shire-Movetis NV
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Main inclusion criteria to be assessed at screening: 1. Subject is a male out-patient =18 years of age (no upper age limit). 2. Subject has a history of constipation, i.e. reports an average of =2 spontaneous bowel movements (SBM)/week that result in a feeling of complete evacuation (SCBM) and one or more of the following for at least 6 months before the selection visit: a) Very hard (little balls) and/or hard stools for at least a quarter of the stools; b) Sensation of incomplete evacuation following for at least a quarter of stools; c) Straining at defecation for at least a quarter of the time. The above criteria are only applicable for SBMs, i.e. BMs 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. 3. Subject agrees to stop his current laxative treatment and is willing to use rescue. Main inclusion criteria to be assessed at baseline (randomisation): 1. During the run-in period, the subject reports an average of =2 SBM/week that result in a feeling of complete evacuation (SCBM).* This includes subjects who never have SBMs. 2. Subject stopped his/her laxative treatment and did not use rescue mediation on more than 75% of days during the run-in period.* medication according to the rescue rule [Dulcolax® (bisacodyl)/ enemas]. 3. Subject did not use disallowed medication during the run-in period. * Excluding the first 7 days for subjects using medication influencing bowel habit or excluding the days between screening and the 7 days following the colonoscopy/sigmoidoscopy for those who had a colonoscopy/sigmoidoscopy after screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 334 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1. Subjects in whom constipation is thought to be drug-induced. 2. Subjects using any disallowed medication. 3. Subjects 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 male subjects with chronic constipation;Secondary Objective: To evaluate the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation;Primary end point(s): The primary parameter is the proportion (%) of subjects with an average of =3 SCBMs/week (i.e. a responder) over the 12-week double-blind treatment period. If e-diary data are available for less than 28 days, the subject will be considered a non-responder for the primary analysis. The Cochran-Mantel-Haenszel test controlling for the randomisation stratification factors (country and CBM) will be used to compare treatment groups. ;Timepoint(s) of evaluation of this end point: The key evaluation period will be the 24-week double-blind trreatment phase. This endpoint will also be evaluated in periods of 4 weeks and per week of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A: • Proportion (%) of subjects with an average increase of =1 (SC)BM/week compared to the run-in period, over the entire treatment period • The average number of (SC)BM/week and change from baseline • Number of (SC)BMs per week: descriptive statistics and distribution in categories as 0, (0;1), [1;2), [2;3), [3;->) • Consistency per (SC)BM: descriptive statistics of 7-point score and % (SC)BM with normal consistency (Type 3 or 4 on the Bristol stool scale) • Straining per (SC)BM: descriptive statistics of 5-point score and % (SC)BM with no straining and with severe/very severe straining • The proportion (%) of subjects with =3 (SC)BM/week and with =50% of (SC)BM with Type 3 or 4 on the Bristol stool scale and mild or moderate straining • Sensation of complete evacuation per (S)BM: % (S)BM with sensation of complete evacuation • Average time to first (SC)BM after the first intake of the trial medication (Day 1) and after the intake on Day 29 (Week 4) • Average number of bisacodyl (Dulcolax®) tablets taken per week and the average number of days with bisacodyl (Dulcolax®) use per week B: • Subject’s global assessment on severity of constipation (5-point scales; 0=none, 4=very severe) • Subject’s global assessment on efficacy of treatment (5-point scales; 0=none, 4=extremely effective) • Subject’s lower GI symptom assessment by the PAC-SYM total score, subscale scores (stool symptoms, abdominal symptoms and rectal symptoms) and individual item scores (5 point scales; 0=none, 4=very severe);Timepoint(s) of evaluation of this end point: A number of secondary parameters will be derived from the e-diary and evaluated over similar periods. The primary parameter and the below secondary parameters in Category A will be evaluated over 12-week and 4 week periods, and per individual week of treatment. Secondary parameters in category B will be summarised per scheduled visits and endpoint (last observation carried forward, LOCF), for both ob | — |
Countries
Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Netherlands, United Kingdom
Contacts
Public ContactShire-Movetis Clinical Trials
Shire-Movetis NV
Outcome results
None listed