- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00142974
Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy
April 19, 2012 updated by: Novartis
This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.
Study Overview
Study Type
Interventional
Enrollment
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel, Switzerland, 4056
- Novartis
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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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years
- GI symptoms for at least 2 months before entering study
Exclusion Criteria:
- Very high body weight
- Significant diarrhea
- Ulcers
Symptom severity score collected via diary 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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.
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Secondary Outcome Measures
Outcome Measure |
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Weekly global measure of dyspeptic symptom relief.
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Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
April 1, 2005
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
April 20, 2012
Last Update Submitted That Met QC Criteria
April 19, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHTF919G2203
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 Diabetic Gastropathy
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Astellas Pharma Europe B.V.Terminated
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Shanghai Jiao Tong University School of MedicineNot yet recruitingNSAID-Associated GastropathyChina
-
Otsuka Pharmaceutical, Inc., PhilippinesCompletedNSAID Induced GastropathyPhilippines
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Daniella Cunha BrandaoAntonio Christian Evangelista Gonçalves; Armèle Dornelas de Andrade; Norma Sueli...Completed
-
The Second Hospital of Nanjing Medical UniversityNot yet recruitingDiabetic Gastroparesis | Diabetic Gastroenteropathy | Diabetic Gastropathy | Diabetic Gastroparesis Associated With Type 2 Diabetes MellitusChina
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Imperial College LondonActegy Ltd.Not yet recruitingDiabetic Neuropathies | Diabetic Peripheral Neuropathy | Diabetic Polyneuropathy | Diabetic ComplicationUnited Kingdom
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AbbVie (prior sponsor, Abbott)CompletedDiabetic Neuropathies | Diabetic Neuropathy, Painful | Diabetic Polyneuropathy | Diabetic Neuralgia | Neuralgia, DiabeticUnited States, Canada, France, Germany, Italy, Mexico, Puerto Rico
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University of ChileClinica Alemana de SantiagoCompletedDIABETIC RETINOPATHY | DIABETES | DIABETIC NEUROPATHYChile
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Retina Institute of HawaiiUnknownDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Severe Nonproliferative Diabetic Retinopathy | Mild Nonproliferative Diabetic Retinopathy | Moderate Nonproliferative Diabetic RetinopathyUnited States
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Corporacion Parc TauliCompletedDiabetic Neuropathy | Diabetic Nerve Problems | Diabetic Complications NeurologicalPakistan
Clinical Trials on Tegaserod
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Hospital Authority, Hong KongNovartisTerminated
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NovartisMayo ClinicWithdrawn
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Fudan UniversityUnknownPneumonia | Cerebral Hemorrhage | Lung InfectionChina
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NovartisCompleted
-
NovartisCompletedDyspepsiaUnited States
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NovartisCompleted
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NovartisCompletedGastroesophageal Reflux Disease (GERD)United States
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NovartisCompletedIBS-C and IBS With Mixed Bowel Habits
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NovartisTerminatedDiabetes | GastroparesisUnited States
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NovartisCompletedChronic ConstipationSwitzerland