Chronic constipation MedDRA version: 14.1 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
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 a history of constipation. The subject reports an average of =2 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 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. 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/her current laxative treatment and is willing to use rescue medication according to the rescue rule [bisacodyl (Dulcolax®)/enemas] Main inclusion criteria to be assessed at randomisation: 1. During the run-in phase the subject reports an average of =2 SBM/week that result in a feeling of complete evacuation (SCBM). 2. Subject stopped his/her laxative treatment and did not use rescue mediation on more than 75% of days during the run-in phase. 3. Subject did not use disallowed medication during the run-in phase. 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 295 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: Main exclusion criteria to be assessed at screening: 1. Subjects in whom constipation is thought to be drug-induced 2. Subjects using any disallowed medication. 3. Subjects who previously used prucalopride. 4. Subjects suffering from secondary causes of chronic constipation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.;Secondary Objective: To evaluate the long-term safety, tolerability and the effect on quality of life of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.;Primary end point(s): The primary endpoint is defined as the proportion (%) of subjects with an average of =3 SCBM/week evaluated over the 24-week treatment phase.;Timepoint(s) of evaluation of this end point: The key evaluation period will be the 24-week double-blind treatment 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: - The proportion of subjects with an average increase of =1 SCBM/week. - The average number of (SC)BM/week and change from baseline. - The 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) and % (SC)BM with hard/very hard consistency (Type 1 or 2 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. - 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 on Day 28 (Week 4). - Average number of bisacodyl (Dulcolax®) tablets taken per week and the 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 gastrointestinal 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). Quality of life data measured at scheduled visits will be analysed by each scheduled visit and at endpoint. For all scores, summary statistics, will be provided as well as tabulations showing the percentage of subjects with an average improvement of = 1 point. ;Timepoint(s) of evaluation of this end point: Secondary parameters in category A will be derived from the e-diary and evaluated over the 24-week treatment period as well as after 4 weeks of treatment and per week of treatment. Secondary parameters in category B will be summarised per scheduled visits and end | — |
Countries
Belgium, Czech Republic, Hungary, Italy, Slovakia, Spain, Sweden
Contacts
Public ContactShire-Movetis Clinical Trials
Shire-Movetis NV
Outcome results
None listed