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

August 12, 2015 updated by: Bayer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
      • Eindhoven, Netherlands, 5623 EJ
      • Veldhoven, Netherlands, 5504 DB
      • Woerden, Netherlands, 3447 GN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Macrogol (Transipeg)
Drug: Macrogol (Transipeg, BAY81-8430)
Up to 4 sachets per day based on individual titration
ACTIVE_COMPARATOR: Macrogol (Forlax)
Drug: Macrogol (Forlax)
Up to 4 sachets per day based on individual titration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks
Time Frame: Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52
Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52
Change From Baseline in Total Sum Score (TSS) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline
Time Frame: Average of Weeks 1 to 8
Average of Weeks 1 to 8
Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline
Time Frame: Average of Weeks 26 and 52
Average of Weeks 26 and 52
Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline
Time Frame: Average up to 52 weeks
Average up to 52 weeks
Dose Range Determination: Mean Dose Based on Sachets Used
Time Frame: Up to 52 weeks.
Up to 52 weeks.
Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used
Time Frame: Up to 52 weeks
Up to 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Treatment Success
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Defecation Frequency
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Consistency of the Feces
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Strains During Defecation
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Quantity of Stools
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects With Pain During Defecation
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Frequency of Pain (Times per Week)
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Percentage of Subjects With Abdominal Pain
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Frequency of Abdominal Pain (Times per Week)
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Relation of Abdominal Pain With Defecation
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects With Urgency for Defecation
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Frequency of Urgency for Defecation (Times per Week)
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week)
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite
Time Frame: Week 1, 2, 4, 8, 12, 26, 52
Week 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Average Score for Diary Reported Diarrhoea
Time Frame: Week 0, 1, 2, 4, 8, 12, 26, 52
Week 0, 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Average Score for Diary Reported Flatulence
Time Frame: Week 0, 1, 2, 4, 8, 12, 26, 52
Week 0, 1, 2, 4, 8, 12, 26, 52
Individual Symptoms: Average Score for Diary Reported Nausea
Time Frame: Week 0, 1, 2, 4, 8, 12, 26, 52
Week 0, 1, 2, 4, 8, 12, 26, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12052
  • 2015-000081-63 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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