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Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

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. Identifier: NCT00171522
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 3, 2016
Information provided by:

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

Condition or disease Intervention/treatment Phase
Constipation Drug: Tegaserod and Polyethylene Glycol 3350 Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00171522

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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

Layout table for additonal information Identifier: NCT00171522    
Other Study ID Numbers: CHTF919EUS49
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016
Keywords provided by Novartis:
Polyethylene Glycol 3350
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Polyethylene glycol 3350
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs