- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00277550
The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia
March 2, 2016 updated by: Novartis
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
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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:
- Less than 3 bowel movements per week
- Hard or lumpy stools
- Straining during bowel movements
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicholas Talley, MD, Mayo Clinic
- Principal Investigator: Michael Crowell, PhD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 13, 2006
First Submitted That Met QC Criteria
January 13, 2006
First Posted (Estimate)
January 16, 2006
Study Record Updates
Last Update Posted (Estimate)
March 4, 2016
Last Update Submitted That Met QC Criteria
March 2, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHTF919EUS42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Constipation and Dyspepsia
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Hospital Universitari Vall d'Hebron Research InstituteCompleted
-
RenJi HospitalRecruitingFunctional Dyspepsia | Constipation-predominant Irritable Bowel SyndromeChina
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Inner Mongolia Yili Industrial Group Co., LtdCompletedDyspepsia | Abdominal Pain | Constipation | FlatulenceChina
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University Hospital, RouenRecruitingDyspepsia | Irritable Bowel Syndrome | Functional Constipation | Faecal IncontinenceFrance
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Carle Physician GroupTerminatedDyspepsia | Nausea | Vomiting | Esophagitis | GERD | Chronic Idiopathic Constipation | GastroparesisUnited States
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Örebro University, SwedenBioGaia ABCompletedAbdominal Pain | Constipation | Diarrhea | Reflux | IndigestionSweden
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St Vincent's Hospital MelbourneCompletedFunctional Dyspepsia | Irritable Bowel Syndrome | Constipation - Functional | Faecal Incontinence | Functional Abdominal Pain Syndrome | Other Rome IV Functional Gastrointestinal DisordersAustralia
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King Chulalongkorn Memorial HospitalRecruiting
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Wuhan Central HospitalNot yet recruiting
-
Dong-A ST Co., Ltd.Not yet recruitingFunctional DyspepsiaKorea, Republic of
Clinical Trials on Tegaserod and Placebo
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NovartisCompleted
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NovartisTerminatedDiabetes | GastroparesisUnited States
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NovartisCompletedChronic ConstipationSwitzerland
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NovartisTerminated