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

NCT00403819 | Completed Phase 3

• 1 other identifier: 2000/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

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

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (1)

• Mean number of complete defaecations per week in each treatment period

Secondary Outcomes (6)

• Mean total number of defaecations (complete plus incomplete) per week in each treatment period

• Pain on defaecation

• Straining on defaecation

• Abdominal pain

• Faecal incontinence

Interventions

Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol) DRUG

Eligibility Criteria

• Age: 24 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• /4 or more of bowel movements with straining
• /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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Norgine: lead

Study Sites (6)

Aberdeen Children's Hospital

Aberdeen, AB25 2ZN, United Kingdom

Location

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

Cardiff, CF14 4XW, United Kingdom

Location

Royal Hospital for Sick Children, University Hospitals NHS Trust

Edinburgh, EH9 1LF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Royal Free Hospital

London, NW3 2PF, United Kingdom

Location

New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 3578195 BACKGROUND

• 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.

  PMID: 3278282 BACKGROUND

• 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.

  PMID: 8244110 BACKGROUND

• 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.

  PMID: 7979489 BACKGROUND

• 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.

  PMID: 8890073 BACKGROUND

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

  PMID: 9830188 BACKGROUND

• 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]

  RESULT

Study Officials

• Michael A Thomson, MD

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2006
• First Posted: November 27, 2006
• Study Start: April 1, 2002
• Study Completion: April 1, 2003
• Last Updated: November 28, 2006

Record last verified: 2006-11

Locations

GB (6)