Movicol in Childhood Constipation (ProMotion Study)

Norgine

Status and phase

Completed

Phase 2

Conditions

Chronic Constipation

Treatments

Drug: Lactulose

Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00404040

99/05 (Part II)

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

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