To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.

PHASE3CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

May 20, 2008

Study Completion Date

May 20, 2008

Conditions
Chronic Constipation
Interventions
DRUG

PEG 4000 (Forlax®)

Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.

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.

Trial Locations (2)

10400

Ramathibodi Hospital, Mahidol University,, Bangkok

30000

Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY