Movicol in Childhood Constipation (ProMotion Study)

Phase 2

Completed

• Conditions: Chronic Constipation

• Registration Number: NCT00404040
• Lead Sponsor: Norgine

Brief Summary

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 out-patient basis. The aim was to evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children

Detailed Description

Two days following disimpaction (Part I of the clinical trial) patients were assigned (based on their randomisation number) to receive either Movicol or Lactulose as maintenance therapy for the remainder of the study. At discharge all patients received the appropriate supply of study medication. This includes 1 week's overage should they miss their next visit to the ProMotion clinic. They did not know whether they have been randomised to receive Movicol or Lactulose Dry.

Following discharge patients were contacted after 3-5 days by telephone or home visit (whichever was appropriate) to encourage treatment and to ensure compliance. Parents were instructed to contact the Pro-Motion team who would advise appropriately if patients had any difficulty i.e. none, irregular and/ or uncomfortable or very loose bowel movements.

The daily use of Movicol or Lactulose Dry during Part II was recorded in the diary. If the dose of Movicol or Lactulose was changed by the Pro-Motion team at any time then it was documented appropriately in the patient notes and the case report form.

Study Timeline

• Study Start: 2000-10
• Study Completion: 2002-07
• Status Verified: 2006-11
• Study First Submitted: 2006-11-24
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Last Update Submitted: 2006-11-27
• Last Update Posted: 2006-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients that, in the opinion of the investigator, are constipated/faecally 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.

Trial Locations

Locations (1)

St Richard's Hospital, Royal West Sussex Hospital NHS Trust; 🇬🇧 Chichester, United Kingdom