Movicol in Childhood Constipation (ProMotion Study)

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404040
• Other study ID #: 99/05 (Part II)
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2006
• Last updated: November 27, 2006
• Start date: October 2000
• Est. completion date: July 2002

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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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

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)

• Lactulose

Locations

Country	Name	City	State
United Kingdom	St Richard's Hospital, Royal West Sussex Hospital NHS Trust	Chichester

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Attar A, Lémann M, Ferguson A, Halphen M, Boutron MC, Flourié B, Alix E, Salmeron M, Guillemot F, Chaussade S, Ménard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30. — View Citation

Candy DC, Edwards D, Geraint M. Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy. J Pediatr Gastroenterol Nutr. 2006 Jul;43(1):65-70 — View Citation

Dalziel SR et al. Efficacy of Movicol in children with faecal impaction. A series of en case histories (A13). British Society of Paediatric Gastroenterologists Annual Meeting. Bristol:21-22, Jan 2000

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.