Movicol in Childhood Constipation (ProMotion Study) - Full Text View

Sponsor:	Norgine
Information provided by:	Norgine
ClinicalTrials.gov Identifier:	NCT00403858

Purpose

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.

Condition	Intervention	Phase
Feces, Impacted	Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol) Drug: Lactulose	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Constipation

Drug Information available for: Lactulose

U.S. FDA Resources

Further study details as provided by Norgine:

Primary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	October 2000
Estimated Study Completion Date:	April 2002

Detailed Description:

Patients received Movicol treatment until disimpaction was achieved according to the following regime:

Day 1: Ages 2 – 4 received 1 (one) sachet whilst 5 – 11 year olds received 2 (two).

Day 2: Ages 2 – 4 received 2 (two) sachets whilst 5 – 11 year olds received 3 (three).

Day 3: Ages 2 – 4 received 2 (two) sachets whilst 5 – 11 year olds received 4 (four).

Day 4: Ages 2 – 4 received 3 *three) sachets whilst 5 – 11 year olds received 5 (five).

Day 5: Ages 2 – 4 received 3 (three) sachets whilst 5 – 11 year olds received 6 (six).

Day 6: Ages 2 – 4 received 4 (four) sachets whilst 5 – 11 year olds received 6 (six).

Day 7: Ages 2 – 4 received 4 (four) sachets whilst 5 – 11 year olds received 6 (six).

If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs. Disimpaction was assessed clinically (loss of faecal masses and passage of watery stools).

Two days following disimpaction patients were randomised (according to the randomisation list) to receive Movicol or Lactulose Dry. During bowel retraining the appropriate maintenance dose of Movicol or Lactulose Dry was determined. Patients were discharged once they were passing regular, painless, bowel actions.

Eligibility

Ages Eligible for Study:	2 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403858

Locations

United Kingdom
St Richard's Hospital, Royal West Sussex Hospital NHS Trust
Chichester, United Kingdom, PO19 4SE

Sponsors and Collaborators

Norgine

Investigators

Principal Investigator:

David CA Candy, MD

St Richard's Hospital

More Information

Publications:

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.

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

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.

Study ID Numbers:	99/05 (Part I)
Study First Received:	November 24, 2006
Last Updated:	January 3, 2007
ClinicalTrials.gov Identifier:	NCT00403858 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Intestinal Obstruction
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Gastrointestinal Agents

Fecal Impaction
Intestinal Diseases
Pharmacologic Actions
Lactulose

ClinicalTrials.gov processed this record on March 18, 2010