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CompletedNCT00139568Updated Feb 1, 2008

An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation

A Phase 3 interventional study of Tegaserod in Constipation, sponsored by Novartis. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-02-01.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Tegaserod is an aminoguanidine indole compound and a member of a new class of 5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves which in turn stimulate contractility and peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic constipation in a Chinese population of adult men and women

02

Conditions studied

  • Constipation

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Keywords

  • Chronic constipation
  • 5-HT,5-HT4,
  • functional GI
  • China
  • tegaserod
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 600 is above the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men or women at least 18 years of age
  • History of constipation for at least 6 months prior to screening
  • Normal bowel evaluation performed within the past 5 years

Exclusion criteria

Exclusion Criteria:

  • Most bothersome symptom in last 6 months is abdominal pain/discomfort
  • Whose chronic constipation is thought to be a result of bowel surgery, gynecological surgery, neurologic disorder, systemic sclerosis, amyloidosis, scleroderma, myotonic dystrophy
  • Insulin dependent diabetes
  • Evidence of cathartic colon or laxative abuse

Other inclusion/exclusion criteria may apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
600 participants

Interventions

  • DrugTegaserod
06

What researchers measure

Primary outcomes

  1. Change from baseline in number of complete spontaneous bowel movements (CSBM) per week

Secondary outcomes

  1. Response rate for CSBM during the first 4 weeks of treatment

  2. Patients' daily assessment of bowel habits

  3. Patients' weekly assessment of constipation symptoms

  4. Satisfactory relief of CC symptoms

  5. PAC-QoL questionnaire

  6. PPSM questionnaire

  7. Safety

07

Study locations

1 site
  • Novartis
    Basel, 4056, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00139568
Lead sponsor
Novartis
First posted
Aug 31, 2005
Start date
Feb 2005
Completion
Oct 2005
Last update
Feb 1, 2008

Study contacts

Novartis
study chair · Novartis Basel, Switzerland
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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