Clinical Trials Logo

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


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00404040
Study type Interventional
Source Norgine
Contact
Status Completed
Phase Phase 2
Start date October 2000
Completion date July 2002

See also
  Status Clinical Trial Phase
Completed NCT05980988 - Effectiveness and Safety of Probiotic in Regulating Chronic Constipation N/A
Recruiting NCT03819062 - Sacral Neuromodulation as Treatment for Chronic Constipation N/A
Completed NCT00730171 - An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT00765882 - Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation Phase 3
Completed NCT00354575 - Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units Phase 2
Active, not recruiting NCT03119584 - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation Phase 4
Completed NCT00765999 - An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT01793753 - Effect of Propofol on Internal Anal Sphincter Pressure During ARM N/A
Completed NCT00746200 - Acupuncture for Chronic Constipation Phase 3
Enrolling by invitation NCT00671684 - Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease Phase 1/Phase 2
Completed NCT00391820 - Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial) Phase 2
Completed NCT02281630 - Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC) Phase 2
Completed NCT00256984 - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS) Phase 4
Recruiting NCT05192317 - Administration of a Natural Molecular Complex in Functional Chronic Constipation N/A
Active, not recruiting NCT05202028 - The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy N/A
Completed NCT05734859 - Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation N/A
Completed NCT01007123 - Study of A3309 in Patients With Chronic Idiopathic Constipation Phase 2
Completed NCT00402337 - Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation Phase 2
Completed NCT02961556 - General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation Phase 3
Recruiting NCT04869280 - Post-Marketing Study of Prucalopride Safety In Pregnancy