To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
|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: NCT00255372|
Recruitment Status : Completed
First Posted : November 18, 2005
Last Update Posted : June 4, 2008
|Condition or disease||Intervention/treatment||Phase|
|Chronic Constipation||Drug: PEG 4000 (Forlax®) Drug: Lactulose active and Lactulose placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Polyethylene Glycol Laxative (Macrogol 4000;Forlax®) for Treatment of Chronic Constipation in Children : A Phase III, Bicentric, Randomized, Double-Blind, Lactulose Controlled Study.|
|Study Start Date :||April 2005|
|Primary Completion Date :||May 2008|
Drug: PEG 4000 (Forlax®)
Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.
|Active Comparator: 2||
Drug: Lactulose active and Lactulose placebo
Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period.
- Bowel movement frequency [ Time Frame: week 4 ]
- Subjective symptoms associated with defecation. [ Time Frame: At every visit ]
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): NCT00255372
|Ramathibodi Hospital, Mahidol University,|
|Bangkok, Thailand, 10400|
|Maharat Nakhon Ratchasima Hospital|
|Nakhon Ratchasima, Thailand, 30000|
|Study Director:||Axel Magis, MD||Ipsen|