Topics

Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children

2014-07-24 14:23:22 | BioPortfolio

Summary

A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an open label post study follow-up, to assess the efficacy and safety of Movicol in the treatment of chronic constipation in children

Description

After a baseline period of 1 (one) week, subjects who had met the inclusion criteria were entered into the treatment phase of the study. Patients were randomised to receive either Movicol or matching Placebo for two (2) weeks. Following the treatment phase, patients underwent a two (2)-week placebo washout period prior to crossing over to receive the alternative treatment e.g. those patients who took Movicol were given the matching Placebo or vice versa on completion of the washout period for two (2) weeks.

On completion of the double blind treatment phase, patients were given the option to participate in the eight (8) week open label post study follow-up. Patients who participated in the post study follow-up received Movicol.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Chronic Constipation

Intervention

Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)

Location

Aberdeen Children's Hospital
Aberdeen
United Kingdom
AB25 2ZN

Status

Completed

Source

Norgine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:23:22-0400

Clinical Trials [819 Associated Clinical Trials listed on BioPortfolio]

Movicol in Childhood Constipation (ProMotion Study)

This was a single centre study comprised of two stages (Parts I and II). Part II was a 12 week randomised double blind comparison of Movicol and Lactulose Dry as maintenance therapy on an...

Movicol in Childhood Constipation (ProMotion Study)

This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day open label evaluation of Movicol administered to patients in hospital. This study evaluated th...

Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.

Study Comparing PEG 3350 Laxative to Placebo in the Treatment of Occasional Constipation (Study CL2007-12)(COMPLETED)

Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took on...

Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste

PubMed Articles [7658 Associated PubMed Articles listed on BioPortfolio]

Severe hypernatremia and transient azotemia in a cat following inadvertent intravenous administration of a commercial polyethylene glycol solution.

To describe the clinical signs, clinicopathologic abnormalities, treatment, and outcome after IV administration of polyethylene glycol 3350 (PEG3350) in a cat.

Effect of polyethylene glycol versus lactulose on abdominal pain in children occult constipation: a randomized controlled study.

Functional abdominal pain (FAP) is one of the major gastrointestinal complaints in childhood. Studies have reported occult constipation (OC) as one of the leading causes of abdominal pain. Recent rese...

Subtype Classification of Functional Constipation in Child: PEG versus Lactulose.

This study aimed to evaluate the usefulness of subtype classification of functional childhood constipation with colon transit time (CTT) test from a therapeutic perspective: polyethylene glycol (PEG) ...

An overview of the efficacy and safety of prucalopride for the treatment of chronic idiopathic constipation.

: Chronic idiopathic constipation (CIC) is a kind of constipation in which the patient experiences constipation more than 3 months without any identifiable cause. Prucalopride is one such treatment co...

Evaluating When and Why Patients Discontinue Chronic Therapy for Irritable Bowel Syndrome With Constipation and Chronic Idiopathic Constipation.

To inform the patient-centered discussion regarding comparative outcomes with irritable bowel syndrome/chronic idiopathic constipation pharmacotherapy, we evaluated reasons and timing of discontinuati...

Medical and Biotech [MESH] Definitions

A network of cross-linked hydrophilic macromolecules used in biomedical applications fabricated by photopolymerization of polyethylene glycol dimethacrylate. Its general formulae is C3H5C(O)(OCH2CH2)nOC(O)C3H5 where n denotes a number of average polyglycol (OCH2CH2) repeats.

Ophthalmic solutions that include LUBRICANTS and WETTING AGENTS such as POLYETHYLENE GLYCOL; HYPROMELLOSE; GLYCEROL; PROPYLENE GLYCOL. They are used to treat conditions caused by deficient tear production such as DRY EYE SYNDROME.

A vinyl polymer made from ethylene. It can be branched or linear. Branched or low-density polyethylene is tough and pliable but not to the same degree as linear polyethylene. Linear or high-density polyethylene has a greater hardness and tensile strength. Polyethylene is used in a variety of products, including implants and prostheses.

Non-ionic surfactant of the polyethylene glycol family. It is used as a solubilizer and emulsifying agent in foods, cosmetics, and pharmaceuticals, often as an ointment base, and also as a research tool.

A copolymer of polyethylene and polypropylene ether glycol. It is a non-ionic polyol surface-active agent used medically as a fecal softener and in cattle for prevention of bloat.

More From BioPortfolio on "Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children"

Quick Search

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...

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'...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial