Pioglitazone for Idiopathic Gastroparesis

• Status: Recruiting
• Trial end date: 2022-09-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Pioglitazone

Criteria

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 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