Movicol in Childhood Constipation (ProMotion Study) - Tabular View

Tracking Information

First Received Date ^ICMJE

November 24, 2006

Last Updated Date

January 3, 2007

Start Date ^ICMJE

October 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00403858 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Movicol in Childhood Constipation (ProMotion Study)

Official Title ^ICMJE

A Single Centre Study to Assess the Safety and Efficacy of Movicol in the Treatment of Faecal Impaction in Children Followed by a Double Blind, Randomised Phase to Compare the Safety and Efficacy of Movicol and Lactulose for Maintenance Therapy

Brief Summary

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 the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered over 3 - 7 days to achieve disimpaction.

Detailed Description

Patients received Movicol treatment until disimpaction was achieved according to the following regime:

Day 1: Ages 2 – 4 received 1 (one) sachet whilst 5 – 11 year olds received 2 (two).

Day 2: Ages 2 – 4 received 2 (two) sachets whilst 5 – 11 year olds received 3 (three).

Day 3: Ages 2 – 4 received 2 (two) sachets whilst 5 – 11 year olds received 4 (four).

Day 4: Ages 2 – 4 received 3 *three) sachets whilst 5 – 11 year olds received 5 (five).

Day 5: Ages 2 – 4 received 3 (three) sachets whilst 5 – 11 year olds received 6 (six).

Day 6: Ages 2 – 4 received 4 (four) sachets whilst 5 – 11 year olds received 6 (six).

Day 7: Ages 2 – 4 received 4 (four) sachets whilst 5 – 11 year olds received 6 (six).

If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs. Disimpaction was assessed clinically (loss of faecal masses and passage of watery stools).

Two days following disimpaction patients were randomised (according to the randomisation list) to receive Movicol or Lactulose Dry. During bowel retraining the appropriate maintenance dose of Movicol or Lactulose Dry was determined. Patients were discharged once they were passing regular, painless, bowel actions.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Feces, Impacted

Intervention ^ICMJE

Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)
Drug: Lactulose

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients that, in the opinion of the investigator, are constipated/fecally impacted as to require hospital stay to treat and/or relieve the impaction
children aged 2 - 11 years old inclusive
patients of either sex

Exclusion Criteria:

Patients with

intestinal perforation or obstruction
severe inflammatory conditions of the intestinal tract
uncontrolled renal/hepatic/cardiac diseases
uncontrolled endocrine disorder(s)
any neuromuscular condition affecting bowel function
hypersensitivity to lactulose or PEG or other constituent of Movicol
patients who have taken any investigational drug in the three months
patients or patients whose parents would in the opinion of the investigator are unable to comply with requirements of the study

Gender

Both

Ages

2 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00403858

Responsible Party

Study ID Numbers ^ICMJE

99/05 (Part I)

Study Sponsor ^ICMJE

Norgine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David CA Candy, MD

St Richard's Hospital

Information Provided By

Norgine

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP