Preference of Tegaserod vs. PEG 3350 in Patients With Constipation
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171522
First received: September 12, 2005
Last updated: January 31, 2008
Last verified: January 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 16, 2013