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

Sponsor:	Norgine
Information provided by:	Norgine
ClinicalTrials.gov Identifier:	NCT00404040

Purpose

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

Condition	Intervention	Phase
Chronic Constipation	Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol) Drug: Lactulose	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
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:

compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.

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

Detailed 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.

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/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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404040

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 II)
Study First Received:	November 24, 2006
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00404040 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Therapeutic Uses
Gastrointestinal Agents

Constipation
Pharmacologic Actions
Lactulose

ClinicalTrials.gov processed this record on February 08, 2010