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A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Subjects With Chronic Constipation

2014-08-27 03:13:59 | BioPortfolio

Summary

The purpose of this study is to compare the efficacy and safety of prucalopride 2 mg given orally once daily for 12 weeks to those of placebo in treatment of chronic constipation. Prucalopride is an investigational drug that is being tested to see if it may be useful in treating chronic constipation.

Description

Prucalopride is new potent, selective and specific serotonin 4 receptor agonist that stimulates the bowel motility. It is being investigated to see if it may be useful in treating chronic constipation. This study will compare the efficacy and safety of prucalopride 2-mg given orally once daily for 12 weeks to those of placebo in the treatment of chronic constipation. Placebo looks like the drug being studied but has no active ingredients. This study consists of 3 phases: a 2-week drug-free screening phase, a 12-week treatment phase, and a posttreatment follow-up contact performed 7 days following the last dose of study drug. The total duration of the patient's participation in the study is approximately 15 weeks. During the screening phase, the patient's bowel habit will be documented and the existence of chronic constipation confirmed. At the start of this phase, all existing laxative medication will be withdrawn and patient will be instructed not to change their diet or lifestyle during the study. Patients will be allowed to take a laxative (bisacodyl) as a rescue medication throughout the trial, but only if they have not had a bowel movement (BM) for three or more consecutive days. No bisacodyl should be taken or enemas used within 48 hours prior to the start of the double-blind treatment (48 hours prior to Day1) and 48 hours following the start of double-blind treatment (48 hours following Day1). The patient will enter the double-blind treatment phase if constipation is shown to be present during the screening phase. If the definition of constipation is not met during the screening period, the patient will be considered ineligible and will be discontinued from the study. During the double-blind treatment phase, the patient will be treated for 12 weeks with 2-mg prucalopride or matching placebo, given orally once daily before breakfast. Patients will record study drug and rescue medication dosing information and information related to bowel movements in a daily diary throughout the study. 2-mg Prucalopride/placebo tablet, given orally once daily for 12 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Constipation

Intervention

placebo, prucalopride 2-mg

Location

Adelaide
Australia

Status

Recruiting

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:59-0400

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Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

Choleretic used to allay dry mouth and constipation due to tranquilizers.

A diphenylmethane stimulant laxative used for the treatment of constipation and for bowel evacuation. (From Martindale, The Extra Pharmacopoeia, 30th ed, p871)

Agents that produce a soft formed stool, and relax and loosen the bowels, typically used over a protracted period, to relieve CONSTIPATION.

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