Movicol in Childhood Constipation (ProMotion Study)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00404040|
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : November 28, 2006
|Condition or disease||Intervention/treatment||Phase|
|Chronic Constipation||Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol) Drug: Lactulose||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||October 2000|
|Estimated Study Completion Date :||July 2002|
- compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404040
|St Richard's Hospital, Royal West Sussex Hospital NHS Trust|
|Chichester, United Kingdom, PO19 4SE|
|Principal Investigator:||David CA Candy, MD||St Richard's Hospital|