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

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ClinicalTrials.gov Identifier: NCT01810653
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Constipation Drug: Macrogol (Transipeg, BAY81-8430) Drug: Macrogol (Forlax) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks [ Time Frame: Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52 ]
  2. Change From Baseline in Total Sum Score (TSS) at Week 52 [ Time Frame: Baseline, Week 52 ]
  3. Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline [ Time Frame: Average of Weeks 1 to 8 ]
  4. Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline [ Time Frame: Average of Weeks 26 and 52 ]
  5. Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline [ Time Frame: Average up to 52 weeks ]
  6. Dose Range Determination: Mean Dose Based on Sachets Used [ Time Frame: Up to 52 weeks. ]
  7. Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used [ Time Frame: Up to 52 weeks ]

Secondary Outcome Measures :
  1. Percentage of Treatment Success [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  2. Individual Symptoms: Defecation Frequency [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  3. Individual Symptoms: Consistency of the Feces [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  4. Individual Symptoms: Strains During Defecation [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  5. Individual Symptoms: Quantity of Stools [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  6. Individual Symptoms: Percentage of Subjects With Pain During Defecation [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  7. Individual Symptoms: Frequency of Pain (Times per Week) [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  8. Percentage of Subjects With Abdominal Pain [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  9. Individual Symptoms: Frequency of Abdominal Pain (Times per Week) [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  10. Individual Symptoms: Relation of Abdominal Pain With Defecation [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  11. 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 ]
  12. Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  13. Individual Symptoms: Percentage of Subjects With Urgency for Defecation [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  14. Individual Symptoms: Frequency of Urgency for Defecation (Times per Week) [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  15. Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  16. Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week) [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  17. Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite [ Time Frame: Week 1, 2, 4, 8, 12, 26, 52 ]
  18. Individual Symptoms: Average Score for Diary Reported Diarrhoea [ Time Frame: Week 0, 1, 2, 4, 8, 12, 26, 52 ]
  19. Individual Symptoms: Average Score for Diary Reported Flatulence [ Time Frame: Week 0, 1, 2, 4, 8, 12, 26, 52 ]
  20. Individual Symptoms: Average Score for Diary Reported Nausea [ Time Frame: Week 0, 1, 2, 4, 8, 12, 26, 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT01810653


Locations
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Netherlands
Amsterdam, Netherlands, 1105 AZ
Eindhoven, Netherlands, 5623 EJ
Veldhoven, Netherlands, 5504 DB
Woerden, Netherlands, 3447 GN
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01810653     History of Changes
Other Study ID Numbers: 12052
2015-000081-63 ( EudraCT Number )
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Keywords provided by Bayer:
Macrogol
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms