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OpenTrials
Completed

NCT Number: NCT00149877

Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.

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Key information

Conditions

Chronic Constipation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Basel, 4056, Switzerland

Who can participate

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

Inclusion criteria

  • Male and females of at least 18 years of age
  • A 12-month history of constipation (defined as < three spontaneous bowel movements per week and ≥1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining)

Exclusion criteria

  • Patients with cancer, inflammatory bowel disease or other structural bowel disease
  • Patients who participated in a prior tegaserod study
  • Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Tegaserod

Drug

Primary outcomes

  1. Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.

Secondary outcomes

  1. Number of csbm during 8 weeks of treatment.

  2. Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.

  3. Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.

  4. Laxative use.

  5. Safety and tolerability.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Sep 8, 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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