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Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00141089
First received: August 31, 2005
Last updated: January 31, 2008
Last verified: January 2008

August 31, 2005
January 31, 2008
March 2004
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Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.
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Complete list of historical versions of study NCT00141089 on ClinicalTrials.gov Archive Site
  • For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm.
  • Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use.
  • Safety and tolerability.
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Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists.

The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Constipation
Drug: Tegaserod
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1026
February 2005
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Inclusion Criteria:

  • A 6-month history of constipation defined as <3 complete 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
  • Past or current diagnosis of irritable bowel syndrome were excluded.

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
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NCT00141089
CHTF919E2309
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Novartis
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Study Chair: Novartis Novartis Basel
Novartis
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP