Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171522
First received: September 12, 2005
Last updated: January 31, 2008
Last verified: January 2008
  Purpose

To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste


Condition Intervention Phase
Constipation
Drug: Tegaserod and Polyethylene Glycol 3350
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use)

Secondary Outcome Measures:
  • n.a.

Estimated Enrollment: 52
Study Start Date: May 2005
Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Females aged 18 to 64 years of age
  • Patients with constipation as defined by the Rome II criteria

Exclusion Criteria:

  • Patients who have been previously been treated with tegaserod and/or PEG 3350
  • Evidence of cathartic colon or a history of laxative abuse or laxative dependence
  • History of fecal impaction which necessitated surgical intervention
  • Patients with clinically significant abnormal TSH levels at screening
  • Women who are pregnant or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171522

Locations
United States, Arizona
Harmony Clinical Research
Oro Valley, Arizona, United States, 85739
Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, United States, 85201
Adobe Gastroenterology, PC
Tucson, Arizona, United States, 85712
United States, California
Associated Pharmaceutical Research Center, Inc
Buena Park, California, United States, 90620
United States, Florida
Clinical Trial Management of Boca Raton, Inc.
Boca Raton, Florida, United States, 33486
United States, Kansas
Health Science Center
Pratt, Kansas, United States, 67124
United States, Massachusetts
Beth Israel Deacon Medical Center
Boston, Massachusetts, United States, 02215
United States, Nebraska
Heartland Clinical Research, Inc
Omaha, Nebraska, United States, 68134
United States, New Jersey
MBS Clinical Research, LLC
Margate, New Jersey, United States, 08402
United States, Ohio
Midwest Clinical Research
Bellbrook, Ohio, United States, 45305
United States, Tennessee
Associates in Gastroenterology
Hermitage, Tennessee, United States, 37076
United States, Texas
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
United States, Virginia
National Clinical Research, Inc
Richmond, Virginia, United States, 23294
East Coast Clinical Research
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00171522     History of Changes
Other Study ID Numbers: CHTF919EUS49
Study First Received: September 12, 2005
Last Updated: January 31, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Constipation
Tegaserod
Polyethylene Glycol 3350
PEG

Additional relevant MeSH terms:
Constipation
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 April 17, 2014