Advertisement

Topics

Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)

2014-07-24 14:15:12 | BioPortfolio

Summary

This study was designed to investigate the clinical safety, tolerability and efficacy of prucalopride in improving the symptoms associated with chronic intestinal pseudo-obstruction (CIP) in subjects with CIP. The study hypothesis was that prucalopride at doses up to 4 mg is safe, well tolerated, efficacious and improves the symptoms associated with CIP.

Description

This phase II, double-blind, placebo-controlled, two-treatment four periods cross-over trial investigated the clinical safety, tolerability and the efficacy of R093877 (prucalopride) in improving the symptoms associated with chronic intestinal pseudo-obstruction (CIP) in subjects with CIP.

Subjects were treated for 4 periods of 12 weeks each with either R093877 2 mg (2 periods) or placebo (2 periods). In each of the first and second 6 month period, there was a placebo (PLA) and an active drug (PRU) treatment period. There were no wash-out periods. In total,7 subjects were randomized; 2 were assigned to the PLA-PRU-PLA-PRU, 2 to the PRUPLA-PRU-PLA, 2 to the PLA-PRU-PRU-PLA, and 1 to the PRU-PLA-PLA-PRU sequence group. Subjects were allowed to use up to 4 mg of prucalopride per day if the 2 mg dose seemed to be insufficient. Two subjects used an average of 3 mg of prucalopride per day during the active drug periods.

Study Design

N/A

Conditions

Chronic Intestinal Pseudo-Obstruction

Intervention

PRU-PLA-PRU-PLA, PLA-PRU-PLA-PRU, PLA-PRU-PRU-PLA, PRU-PLA-PLA-PRU

Location

Northwick Park Hospital
London
United Kingdom

Status

Completed

Source

Movetis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:15:12-0400

Clinical Trials [358 Associated Clinical Trials listed on BioPortfolio]

Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-Year Manometric Follow-Up

Small bowel involvement is still recognized to be associated with great morbidity and mortality in SSc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. In...

Use of Gastrografin in the Management of Fecal Impaction in Patients With Intractable Constipation

Fecal impaction (FI) is a common cause of lower gastrointestinal tract obstruction, and it is the result of chronic or severe constipation and most commonly found in the elderly population...

Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associat...

Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients

The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This effec...

Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve

Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids thr...

PubMed Articles [9485 Associated PubMed Articles listed on BioPortfolio]

Clinical strategies for the management of intestinal obstruction and pseudo-obstruction. A Delphi Consensus study of SICUT (Società Italiana di Chirurgia d'Urgenza e del Trauma).

Intestinal obstructions/pseudo-obstruction of the small/large bowel are frequent conditions but their management could be challenging. Moreover, a general agreement in this field is currently lacking,...

Clinical Features, Morbidity, and Risk Factors of Intestinal Pseudo-obstruction in Systemic Lupus Erythematosus: A Retrospective Case-control Study.

To analyze the epidemiology, clinical characteristics, and risk factors for systemic lupus erythematosus-related intestinal pseudo-obstruction (SLE-IPO).

Enteric neuropathies: Yesterday, Today and Tomorrow.

Enteric neuropathy is a term indicating an impairment of the innervation supplying the gastrointestinal tract. The clinical phenotypes of the enteric neuropathies are the 'tip of the iceberg' of sever...

Mitochondrial respiratory chain complex IV deficiency complicated with chronic intestinal pseudo-obstruction in a neonate.

A female infant born at 36 weeks gestational age with birthweight 2135 g, and who developed respiratory disorder, hyperlactacidemia and hypertrophic cardiomyopathy after birth, was admitted to hospita...

Anastomotic Leakage in a Patient with Acute Intestinal Obstruction Secondary to Appendiceal and Ileal Endometriosis: A Case Report.

Endometriosis is a commonly encountered problem in women of reproductive age. It usually causes chronic abdominal pain. However, it rarely causes complications such as intestinal obstruction. The most...

Medical and Biotech [MESH] Definitions

A type of ILEUS, a functional not mechanical obstruction of the INTESTINES. This syndrome is caused by a large number of disorders involving the smooth muscles (MUSCLE, SMOOTH) or the NERVOUS SYSTEM.

A condition caused by the lack of intestinal PERISTALSIS or INTESTINAL MOTILITY without any mechanical obstruction. This interference of the flow of INTESTINAL CONTENTS often leads to INTESTINAL OBSTRUCTION. Ileus may be classified into postoperative, inflammatory, metabolic, neurogenic, and drug-induced.

Functional obstruction of the COLON leading to MEGACOLON in the absence of obvious COLONIC DISEASES or mechanical obstruction. When this condition is acquired, acute, and coexisting with another medical condition (trauma, surgery, serious injuries or illness, or medication), it is called Ogilvie's syndrome.

Blockage in any part of the URETER causing obstruction of urine flow from the kidney to the URINARY BLADDER. The obstruction may be congenital, acquired, unilateral, bilateral, complete, partial, acute, or chronic. Depending on the degree and duration of the obstruction, clinical features vary greatly such as HYDRONEPHROSIS and obstructive nephropathy.

Dilatation of the intestinal lymphatic system usually caused by an obstruction in the intestinal wall. It may be congenital or acquired and is characterized by DIARRHEA; HYPOPROTEINEMIA; peripheral and/or abdominal EDEMA; and PROTEIN-LOSING ENTEROPATHIES.

More From BioPortfolio on "Efficacy Study of Prucalopride to Treat Chronic Intestinal Pseudo-Obstruction (CIP)"

Quick Search
Advertisement
 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

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...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial