Pioglitazone for Idiopathic Gastroparesis (NCT04300127) | Clinical Trial Compass
CompletedEarly Phase 1
Pioglitazone for Idiopathic Gastroparesis
United States14 participantsStarted 2019-10-24
Plain-language 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 with Idiopathic Gastroparesis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 …
What they're measuring
1
Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index
Timeframe: Baseline, later monthly up to 3 months.