CClinicalTrials.gg
Sign In
CompletedNCT00255372Updated Apr 24, 2020

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

A Phase 3 interventional study of PEG 4000 (Forlax®) and Lactulose active and Lactulose placebo in Chronic Constipation, sponsored by Ipsen. Completed at 2 sites in Thailand. Open to participants aged 12 Months to 36 Months. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by Ipsen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
12 Months to 36 Months
Sex
All
01

Study summary

The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.

02

Conditions studied

  • Chronic Constipation

Browse trials for

03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 88 is close to the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic constipation (defined as at least 3 months of less than 2 bowel movements (BMs) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis)
  • Constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy

Exclusion criteria

Exclusion Criteria:

  • Organic bowel diseases
  • Suspected GI obstruction
  • History of GI surgery
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    1

    Drug: PEG 4000 (Forlax®)

  • Active comparator
    2

    Drug: Lactulose active and Lactulose placebo

Interventions

  • DrugPEG 4000 (Forlax®)

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

  • DrugLactulose 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.

06

What researchers measure

Primary outcomes

  1. Bowel movement frequency

    Time frame: week 4

Secondary outcomes

  1. Subjective symptoms associated with defecation.

    Time frame: At every visit

07

Study locations

2 sites
  • Ramathibodi Hospital, Mahidol University,
    Bangkok, 10400, Thailand
  • Maharat Nakhon Ratchasima Hospital
    Nakhon Ratchasima, 30000, Thailand
08

References and documents

Publications

  • Treepongkaruna S, Simakachorn N, Pienvichit P, Varavithya W, Tongpenyai Y, Garnier P, Mathiex-Fortunet H. A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children. BMC Pediatr. 2014 Jun 19;14:153. doi: 10.1186/1471-2431-14-153. PubMed 24943105 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00255372
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Nov 18, 2005
Start date
Apr 2005
Primary completion
May 20, 2008
Completion
May 20, 2008
Last update
Apr 24, 2020

Study contacts

Ipsen Medical Director
study director · Ipsen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Constipation→

Other studies from this sponsor

Ipsen

Start the discussion