Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Gastroparesis
Type
Interventional
Phase
Early Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Pilot studyMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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:...

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.

Tracking Information

NCT #
NCT04300127
Collaborators
Not Provided
Investigators
Principal Investigator: Pankaj J Pasricha, MD Johns Hopkins University
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