Early Phase 1
N=14
Pioglitazone for Idiopathic Gastroparesis
Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT04300127 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index — 2.9; 2.3; 2.2; 2.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Pioglitazone 30 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index |
2.9; 2.3; 2.2; 2.6 | — |
| SECONDARY Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) |
2.6; 1.9; 1.9; 2.3 | — |
| SECONDARY Functional Status as Assessed by the SF-36v2 Health Survey |
54.3; 64.6; 67.1; 64.6; 40.2; 51.3 | — |
| SECONDARY C- Reactive Protein Level in Blood |
2.5; 5.1 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
14.5; 14.8 | — |
| SECONDARY Mood as Assessed by the Beck Depression Inventory |
17.9; 8.6; 8.8; 12.6 | — |
| SECONDARY Mood as Assessed by the State-Trait Anxiety Inventory |
44.1; 35.8; 38.7; 36.8; 43.3; 33.9 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT04300127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.