Pioglitazone for Idiopathic Gastroparesis

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Diary (GCSI-DD) in patients with Idiopathic Gastroparesis Secondary objectives of this study include: - To determine the effects of pioglitazone on other symptoms associated with gastroparesis using the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) and the Gastrointestinal Symptom Rating Scale (GSRS), - To determine the effects of pioglitazone on gastric emptying as measured by the 13C- Spirulina breath test, - To determine the effects of pioglitazone on satiety as measured by a liquid caloric test - To determine the effects of pioglitazone on depression and anxiety using the Beck Depression Inventory and State-Trait Anxiety Scores, - To determine the effects of pioglitazone on Quality of Life using the PAGI-QoL and Short Form (SF)-36 questionnaire, - To determine the effects of pioglitazone on markers of inflammation (CRP and ESR) and serum cytokine levels - To determine the nature and incidence of adverse effects from a 12-week course of pioglitazone. Treatment group • Pioglitazone (30 mg po qd) Population • Age 18 years or older at registration with nausea, vomiting, and other symptoms suggestive of patients with chronic nausea and vomiting of presumed gastric origin, with symptomatic gastroparesis. Study duration - Up to 4 weeks of screening prior to pioglitazone treatment - 8 weeks of treatment starting at initial dose of pioglitazone - 4 weeks of washout period - Length of recruitment: 16 months Sample size justification - Total of 10 patients - Primary comparison: Baseline PAGI-SYM score versus 4, 8, and 12 weeks. Number of clinical centers • Johns Hopkins Bayview Medical Center. ;

Study Design

Related Conditions & MeSH terms

Gastroparesis

Clinical Trial Details

NCT number	NCT04300127
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Active, not recruiting
Phase	Early Phase 1
Start date	October 24, 2019
Completion date	October 29, 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pioglitazone for Idiopathic Gastroparesis — PIOGAS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms