Study Stopped
This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis
An Open-label Pilot Trial to Assess the Effect of Tegaserod on Improvement of Gastric Emptying in Patients With Diabetic Gastroparesis and Upper Gastrointestinal Symptoms
1 other identifier
interventional
40
1 country
3
Brief Summary
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2007
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2006
CompletedFirst Posted
Study publicly available on registry
October 23, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMay 4, 2012
May 1, 2012
2 months
October 20, 2006
May 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET)
Secondary Outcomes (5)
Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying
Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort
Volume and symptomatic response to a gastric satiety drink test (GSDT)
Electrogastrography (EGG)
The safety and tolerability of tegaserod
Interventions
Eligibility Criteria
You may qualify if:
- Females and males 18 to 75 years of age
- History of type I or type II diabetes mellitus for more than 3 years
- History of upper gastrointestinal symptoms consistent with diabetic gastroparesis
- Hemoglobin A1c \< 9.5%
- Delayed gastric emptying
You may not qualify if:
- Abnormal endoscopy finding that can explain the presence of gastroparesis symptoms
- Medical conditions affecting gastric emptying
- A clinically significant medical condition that would interfere with the patient completing the trial
- Clinically significant abnormal creatinine level
- Known allergies to the same class of drug and/or allergies to eggs
- Severe obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (3)
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
The University of Louisville
Louisville, Kentucky, 40292, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceutical Corporation
NPC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 20, 2006
First Posted
October 23, 2006
Study Start
January 1, 2007
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
May 4, 2012
Record last verified: 2012-05