Advertisement

Topics

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 At the start of this phase, all existing laxative medication will be withdrawn and patient will be instructed not to change their diet or lifestyle during the study.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

Clinical Trials [276 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety Study of Prucalopride for the Treatment of Patients With Chronic Constipation

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation Hypothesis: Prucalopride 2 mg and 4 mg given once dail...

Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation. Hypothesis: Prucalopride 2 mg and 4 mg given once dai...

Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation in elderly patients. Hypothesis: Prucalopride 2 mg and...

Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic constipation. Hypothesis: Prucalopride 1 and 2 mg bid are safe a...

Prucalopride in Patients With Chronic Idiopathic Constipation

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic idiopathic constipation. Hypothesis: Prucalopride given at a dose o...

PubMed Articles [992 Associated PubMed Articles listed on BioPortfolio]

Effects of psyllium vs. placebo on constipation, weight, glycemia, and lipids: A randomized trial in patients with type 2 diabetes and chronic constipation.

To compare the effects of baked psyllium supplementation versus those who received a placebo on constipation symptoms, body weight, glycemic and lipids control in patients with type 2 diabetes (T2D) a...

"I Can't Poop": Medication-Induced Constipation.

One of the challenging side effects of many medications is constipation. When knowledgeable nurses who teach patients about their medications include information about the possibility of constipation,...

Lack of Benefit of Lactobacillus Reuteri DSM 17938 as an Addition to the Treatment of Functional Constipation.

The aim of this study was to investigate the role of Lactobacillus (L.) reuteri DSM 17983 in the treatment of functional constipation in children. The trial was a single-center randomized, double-blin...

Prucalopride Inhibits Proliferation of Ovarian Cancer Cells via Phosphatidylinositol 3-Kinase (PI3K) Signaling Pathway.

BACKGROUND Ovarian cancer is the second most common malignant tumor of the female reproductive system and is the leading cause of death of gynecological malignancies, but at present there is no effect...

Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial.

Mizagliflozin is a novel oral sodium-glucose cotransporter 1 (SGLT1) inhibitor that increases luminal glucose and water. This study assessed the efficacy and safety of mizagliflozin in patients with f...

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.

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

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Gastroenterology
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...


Searches Linking to this Trial