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The Effects of Tegaserod Vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00277550
First received: January 13, 2006
Last updated: September 7, 2006
Last verified: September 2006
History of Changes
  Purpose

To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia


Condition Intervention Phase
Constipation and Dyspepsia
 Drug: Tegaserod and Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Effects of Tegaserod (6 Mg b.i.d) on Whole Gut Transit Time in Patients With Chronic Idiopathic Constipation and Dyspepsia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.

Secondary Outcome Measures:
  • To evaluate the PD effects of tegaserod on upper & lower GI transit
  • To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments

Estimated Enrollment: 64
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females aged 18 to 64 years of age

  • Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:

    1. Less than 3 bowel movements per week
    2. Hard or lumpy stools
    3. Straining during bowel movements
    4. Feeling of incomplete evacuation
  • Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating

Exclusion Criteria:

  • Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives
  • Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians
  • Patients with constipation secondary to medication use as determined by the study physician
  • Patients with clinically significant abnormal TSH levels at screening
  • Patients that have heartburn or abdominal pain as their predominant GI symptom

  • Evidence of cathartic colon or a history of laxative abuse

    • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277550

Sponsors and Collaborators
Novartis
Mayo Clinic
Investigators
Principal Investigator: Nicholas Talley, MD Mayo Clinic
Principal Investigator: Michael Crowell, PhD Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00277550     History of Changes
Other Study ID Numbers: CHTF919EUS42
Study First Received: January 13, 2006
Last Updated: September 7, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Constipation, Tegaserod, Dyspepsia

Additional relevant MeSH terms:
Constipation
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Tegaserod
Serotonin Receptor Agonists
 Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013