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

• ClinicalTrials.gov Identifier: NCT00403819
• Recruitment Status: Completed
• First Posted: November 27, 2006
• Last Update Posted: November 28, 2006
• Sponsor: Norgine
• Information provided by: Norgine

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Chronic Constipation	Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)	Phase 3

Detailed 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

• Study Type: Interventional (Clinical Trial)
• Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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
• Study Start Date: April 2002
• Study Completion Date: April 2003

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Mean number of complete defaecations per week in each treatment period

Secondary Outcome Measures :

1. Mean total number of defaecations (complete plus incomplete) per week in each treatment period
2. Pain on defaecation
3. Straining on defaecation
4. Abdominal pain
5. Faecal incontinence
6. Stool consistency

Eligibility Criteria

• Ages Eligible for Study: 24 Months to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United Kingdom

Aberdeen Children's Hospital

Aberdeen, United Kingdom, AB25 2ZN

University Hospital of Wales, Children's Hospital, North Ward

Cardiff, United Kingdom, CF14 4XW

Royal Hospital for Sick Children, University Hospitals NHS Trust

Edinburgh, United Kingdom, EH9 1LF

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Royal Free Hospital

London, United Kingdom, NW3 2PF

New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, United Kingdom, WV10 0QP

Sponsors and Collaborators

Norgine

Investigators

• Principal Investigator: Michael A Thomson, MD; Royal Free Hospital NHS Foundation Trust

More Information

Publications of Results:

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]

Other Publications:

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. doi: 10.1001/archpedi.1987.04460060095043.

Hatch TF. Encopresis and constipation in children. Pediatr Clin North Am. 1988 Apr;35(2):257-80. doi: 10.1016/s0031-3955(16)36431-8.

Loening-Baucke V. Constipation in early childhood: patient characteristics, treatment, and longterm follow up. Gut. 1993 Oct;34(10):1400-4. doi: 10.1136/gut.34.10.1400.

Benninga MA, Buller HA, Heymans HS, Tytgat GN, Taminiau JA. Is encopresis always the result of constipation? Arch Dis Child. 1994 Sep;71(3):186-93. doi: 10.1136/adc.71.3.186.

Benninga MA, Buller 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. doi: 10.1097/00005176-199610000-00007.

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

• ClinicalTrials.gov Identifier: NCT00403819
• Other Study ID Numbers: 2000/01
• First Posted: November 27, 2006
• Last Update Posted: November 28, 2006
• Last Verified: November 2006

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive; Polyethylene glycol 3350; Laxatives; Gastrointestinal Agents