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ConstipationPhase 4NCT01810653

A Study to Compare the Effect of Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation

A Phase 4 study testing Macrogol (Transipeg, BAY81-8430) and Macrogol (Forlax) in people with Constipation, run by Bayer at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study design combines a long-term safety and a dose range determination objective. The first 8 weeks of the study were primarily intended for the dose range determination, while the later visits were used for the comparison of long-term safety between the groups. Read more about this study

Who is it for?
Ages 6 months to 15 years
Conditions the study is for
Constipation
What is being tested?
Macrogol (Transipeg, BAY81-8430) and Macrogol (Forlax)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
4 sitesNetherlands
Study dates
Apr 2006to Dec 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Childhood functional constipation
  • 6 months to <16 years of age
  • Male or female
  • For females of childbearing potential (after menarche): negative pregnancy test
  • Moderately severe to severe constipation, defined as stool frequency <3 stools/week
  • Informed consent signed by parent(s) or legal acceptable representative(s), after sufficient oral and written information before entering the study, to be documented by the investigators in the Case Report Form

Who cannot join

  • Functional non-retentive fecal incontinence
  • Known metabolic or endocrine disorders (s.a. hypothyroidism)
  • Neurologic disorders (s.a. spina bifida or spinal cord anomaly)
  • Hirschsprung's disease (congenital megacolon)
  • Anal anomaly
  • Gastrointestinal surgery
Show all 16Show fewer
  • Drug induced constipation
  • Mental retardation
  • Cerebral palsy
  • Treatment with other laxatives
  • Drugs influencing gastrointestinal function (e.g., cisapride, erythromicin, imodium)
  • Prior bowel surgery, except appendectomy
  • Earlier participation in this trial
  • Concurrent participation in any other clinical trial
  • Participation in any other clinical study 6 months prior to inclusion
  • Any use of a Macrogol within 2 months prior to inclusion

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Veldhoven, 5504 DB

  • Study site

    Woerden, 3447 GN

Other trials in Netherlands

About this study

Official title: A Double-blind, Randomized, Uninational, Multicenter, Two Parallel Groups, Active Controlled Study to Compare the Effect of the Treatment With Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation

The study design combines a long-term safety and a dose range determination objective. The first 8 weeks of the study were primarily intended for the dose range determination, while the later visits were used for the comparison of long-term safety between the groups.

Conditions
Constipation
Being tested
Macrogol (Transipeg, BAY81-8430), Macrogol (Forlax)
Keywords
Macrogol
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Macrogol (Transipeg, BAY81-8430)Drug

    Up to 4 sachets per day based on individual titration

  • Macrogol (Forlax)Drug

    Up to 4 sachets per day based on individual titration

Study groups in NCT01810653
Study groupRoleWhat they receive
Macrogol (Transipeg)ExperimentalNot described
Receives: Drug: Macrogol (Transipeg, BAY81-8430)
Macrogol (Forlax)Active comparatorNot described
Receives: Drug: Macrogol (Forlax)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks

    Measured: Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52

  2. Change From Baseline in Total Sum Score (TSS) at Week 52

    Measured: Baseline, Week 52

  3. Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline

    Measured: Average of Weeks 1 to 8

  4. Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline

    Measured: Average of Weeks 26 and 52

  5. Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline

    Measured: Average up to 52 weeks

  6. Dose Range Determination: Mean Dose Based on Sachets Used

    Measured: Up to 52 weeks.

  7. Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used

    Measured: Up to 52 weeks

Secondary outcomes (20)

  1. Percentage of Treatment Success

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  2. Individual Symptoms: Defecation Frequency

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  3. Individual Symptoms: Consistency of the Feces

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  4. Individual Symptoms: Strains During Defecation

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  5. Individual Symptoms: Quantity of Stools

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  6. Individual Symptoms: Percentage of Subjects With Pain During Defecation

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  7. Individual Symptoms: Frequency of Pain (Times per Week)

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  8. Percentage of Subjects With Abdominal Pain

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  9. Individual Symptoms: Frequency of Abdominal Pain (Times per Week)

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  10. Individual Symptoms: Relation of Abdominal Pain With Defecation

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  11. Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  12. Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  13. Individual Symptoms: Percentage of Subjects With Urgency for Defecation

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  14. Individual Symptoms: Frequency of Urgency for Defecation (Times per Week)

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  15. Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  16. Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week)

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  17. Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite

    Measured: Week 1, 2, 4, 8, 12, 26, 52

  18. Individual Symptoms: Average Score for Diary Reported Diarrhoea

    Measured: Week 0, 1, 2, 4, 8, 12, 26, 52

  19. Individual Symptoms: Average Score for Diary Reported Flatulence

    Measured: Week 0, 1, 2, 4, 8, 12, 26, 52

  20. Individual Symptoms: Average Score for Diary Reported Nausea

    Measured: Week 0, 1, 2, 4, 8, 12, 26, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2013 (estimated)
  2. Study startApr 2006
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01810653
Sponsor's protocol ID
12052
Other IDs
2015-000081-63, 2015
Status last verified
Aug 2015
First submitted
12 Mar 2013
Last updated
13 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bekkali NLH, Hoekman DR, Liem O, Bongers MEJ, van Wijk MP, Zegers B, Pelleboer RA, Verwijs W, Koot BGP, Voropaiev M, Benninga MA. Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):10-15. doi: 10.1097/MPG.0000000000001726.

    PubMed 28906317

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Macrogol (Transipeg, BAY81-8430) and Macrogol (Forlax) in people with Constipation, run by Bayer at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks (time frame: Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01810653, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.

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