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

Chronic Constipation Clinical Trial

Official title:

A Phase III Multi-Centre Placebo-Controlled Crossover Study Followed by an Open Label Post-Study Follow-up to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403819
• Other study ID #: 2000/01
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2006
• Last updated: November 27, 2006
• Start date: April 2002
• Est. completion date: April 2003

Study information

• Verified date: November 2006
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 11 Years

Eligibility

Inclusion Criteria:

Male and female patients of any ethnic origin will be eligible to participate in the study if all of the following criteria are fulfilled.

• informed consent having been obtained from the patient's parent or guardian and assent from the child if they are capable of understanding the study

• aged 24 months - 11 years

• experiencing constipation as defined as:

• =2 complete bowel movements per week, and at least one of the following:

• pain on defaecation on =1 in 4 days

• 1/4 or more of bowel movements with straining

• 1/4 or more of bowel movements with hard or lumpy stools

• patients in whom these symptoms have been present for =3 months

• available to complete the study and able to comply with requirements and restrictions listed in the patient's/parent's information documents.

Exclusion Criteria:

Patients will not be eligible to participate in the study if any of the following conditions apply:

• faecal impaction or history of faecal impaction

• history of intestinal perforation or constipation

• paralytic ileus

• toxic megacolon

• Hirschsprungs disease

• severe inflammatory conditions of the intestinal tract

• severe gastro-oesophageal reflux - that which is complicated by anaemia, haematemesis, respiratory aspiration, failure to thrive or other recognised complications of gastro-oesophageal reflux

• patients currently receiving over 0.5mg/kg/day of senna or over 1/2 sachet of sodium picosulphate per day for children <6 years and over 1 sachet sodium picosulphate per day for children > 6 years (i.e. high doses of stimulant laxatives)

• any other significant medical condition that in the investigator's opinion would effect their suitability for entry into the study

• patients who have previously received Movicol or previously participated in the study

• known hypersensitivity to polyethylene (PEG) 3350 or any of the constituents of Movicol

• patients with diabetes as the placebo to be used in this study is sucrose

• patients who have received any investigational drug in the last 3 months

• patients and/or parents who the investigator thinks could not comply with the requirements of the protocol for any reason (particularly in relation to reliable completion of diary cards)

Study Design

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)

Locations

Country	Name	City	State
United Kingdom	Aberdeen Children's Hospital	Aberdeen
United Kingdom	University Hospital of Wales, Children's Hospital, North Ward	Cardiff
United Kingdom	Royal Hospital for Sick Children, University Hospitals NHS Trust	Edinburgh
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Royal Free Hospital	London
United Kingdom	New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Benninga MA, Büller HA, Heymans HS, Tytgat GN, Taminiau JA. Is encopresis always the result of constipation? Arch Dis Child. 1994 Sep;71(3):186-93. — View Citation

Benninga MA, Büller HA, Tytgat GN, Akkermans LM, Bossuyt PM, Taminiau JA. Colonic transit time in constipated children: does pediatric slow-transit constipation exist? J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):241-51. — View Citation

Culbert P, Gillett H, Ferguson A. Highly effective new oral therapy for faecal impaction. Br J Gen Pract. 1998 Sep;48(434):1599-600. — View Citation

Hatch TF. Encopresis and constipation in children. Pediatr Clin North Am. 1988 Apr;35(2):257-80. Review. — View Citation

Issenman RM, Hewson S, Pirhonen D, Taylor W, Tirosh A. Are chronic digestive complaints the result of abnormal dietary patterns? Diet and digestive complaints in children at 22 and 40 months of age. Am J Dis Child. 1987 Jun;141(6):679-82. — View Citation

Loening-Baucke V. Constipation in early childhood: patient characteristics, treatment, and longterm follow up. Gut. 1993 Oct;34(10):1400-4. — View Citation

Thomson M, Jenkins H, et al. A Placebo Controlled Crossover Study of Movicol in the Treatment of Childhood Constipation. J Pediatr Gastroenterol Nutr 2004;39(1):S16 [abstract]

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of complete defaecations per week in each treatment period
Secondary	Mean total number of defaecations (complete plus incomplete) per week in each treatment period
Secondary	Pain on defaecation
Secondary	Straining on defaecation
Secondary	Abdominal pain
Secondary	Faecal incontinence
Secondary	Stool consistency