Status:
COMPLETED
Pioglitazone for Idiopathic Gastroparesis
Lead Sponsor:
Johns Hopkins University
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The principal objective of this pilot study will be to evaluate whether 8 weeks of treatment of pioglitazone will improve symptoms as measured by the Gastrointestinal Symptom Index (GCSI) in patients ...
Detailed Description
Objective • The principal objective of this pilot study will be to evaluate whether 8 weeks of treatment of pioglitazone will improve symptoms as measured by the Gastrointestinal Symptom Index Daily D...
Eligibility Criteria
Inclusion
- Age 18 years or older at registration
- Diagnosis of gastroparesis as documented by gastric emptying scintigraphy (4-hour emptying after a low-fat meal with any combination of 2 and 4 hour retention of \>60% and 10% respectively)
- Ongoing symptoms referable to gastroparesis (i.e. Nausea and vomiting, bloating, and abdominal pain)
- Exclusion of other causes of symptoms such as mechanical gastrointestinal obstruction, uncontrolled esophagitis, peptic ulcer disease, etc. By standard radiographic or endoscopic tests
- Females will be required to use adequate contraceptive methods during study participation as determined by the Principal Investigator and the study team members
Exclusion
- Another active disorder, which could explain symptoms in the opinion of the investigator
- Age \< than 18 years
- Pregnancy or nursing
- Previous surgery of the upper gastrointestinal tract, including vagotomy
- Another active disorder, which could explain symptoms in the opinion of the investigator
- Use of narcotics more than 3 days per week
- Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2 x upper limit of normal (ULN) or a Child-Pugh score of 10 or greater
- Serious systemic disease, such as recent myocardial infarction/unstable angina, decompensated congestive heart failure, severe pulmonary disease with dyspnea at rest, or altered mental status from any cause
- Diabetes as defined by HbA1c \>6.5 and/or fasting blood sugar of \>125 mg/DL
- Contraindications to pioglitazone such as hypersensitivity or allergy
- Concurrent use of: estradiol, ethynyl estradiol, mestranol, pazopanib, warfarin, digoxin, atorvastatin, ranitidine, gemfibrozil, fexofenadine, midazolam
- Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
- History of bladder cancer or family history of bladder cancer
- Failure to give informed consent
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04300127
Start Date
October 24 2019
End Date
March 18 2025
Last Update
April 30 2025
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224