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OpenTrials
Completed

NCT Number: NCT00139568

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

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

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Tegaserod

Drug

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Aug 31, 2005
Registry last updated
Feb 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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