Effects of prucalopride on opioid induced constipation in patients with chronic non-cancer pai

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 342

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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.<br>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 Outcome Measures

Name	Time	Method

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GlaxoSmithKline Research and Development Ltd

Updated 3/19/2012