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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00277550
First Posted: January 16, 2006
Last Update Posted: March 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Novartis
January 13, 2006
January 16, 2006
March 4, 2016
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To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
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Complete list of historical versions of study NCT00277550 on ClinicalTrials.gov Archive Site
  • 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
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The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia
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
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia
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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Constipation and Dyspepsia
Drug: Tegaserod and Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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
Sexes Eligible for Study: Female
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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United States
 
NCT00277550
CHTF919EUS42
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Novartis
Novartis
Mayo Clinic
Principal Investigator: Nicholas Talley, MD Mayo Clinic
Principal Investigator: Michael Crowell, PhD Mayo Clinic
Novartis
March 2016

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