Movicol in Childhood Constipation (ProMotion Study)

NCT00403858 | Completed Phase 2

• 1 other identifier: 99/05 (Part I)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day open label evaluation of Movicol administered to patients in hospital. This study evaluated the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered over 3 - 7 days to achieve disimpaction.

Conditions

Feces, Impacted

Outcome Measures

Primary Outcomes (1)

• evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.

Interventions

Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol) DRUG

Lactulose DRUG

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients that, in the opinion of the investigator, are constipated/fecally impacted as to require hospital stay to treat and/or relieve the impaction
• children aged 2 - 11 years old inclusive
• patients of either sex

You may not qualify if:

• 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

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

St Richard's Hospital, Royal West Sussex Hospital NHS Trust

Chichester, PO19 4SE, United Kingdom

Location

Related Publications (3)

• 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

  BACKGROUND

• Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard 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. doi: 10.1136/gut.44.2.226.

  PMID: 9895382 BACKGROUND

• 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. doi: 10.1097/01.mpg.0000228097.58960.e6.

  PMID: 16819379 RESULT

MeSH Terms

Conditions

Fecal Impaction

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• David CA Candy, MD

  St. Richard's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2006
• First Posted: November 27, 2006
• Study Start: October 1, 2000
• Study Completion: April 1, 2002
• Last Updated: January 4, 2007

Record last verified: 2007-01

Locations

GB (1)