Pioglitazone for Gastroparesis

(PIOGAS Trial)

Overseen By Guillermo Barahona, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Johns Hopkins University

Must not be taking: Narcotics, Estradiol, Warfarin, others

Disqualifiers: Pregnancy, Diabetes, Bladder cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

14 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including estradiol, ethynyl estradiol, mestranol, pazopanib, warfarin, digoxin, atorvastatin, ranitidine, gemfibrozil, fexofenadine, and midazolam. If you are on any of these, you would need to discontinue them to participate.

How does the drug Pioglitazone differ from other treatments for gastroparesis?

Pioglitazone is unique for gastroparesis as it is primarily used for diabetes and works by improving insulin sensitivity, unlike other treatments like domperidone or cisapride, which are prokinetics that directly enhance stomach motility. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing whether pioglitazone, a diabetes medication, can help adults with chronic nausea and vomiting due to gastroparesis. The medication works by reducing inflammation and improving insulin response, which might improve stomach function.

Research Team

Glenn J Treisman, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Adults with Idiopathic Gastroparesis, confirmed by gastric emptying tests, can join this trial. They must have ongoing symptoms like nausea and vomiting. Pregnant or nursing individuals, those under 18, with a history of bladder cancer or significant liver disease, recent severe heart issues, uncontrolled other diseases that could explain symptoms, previous upper GI tract surgery or diabetes are excluded.

Inclusion Criteria

Females will be required to use adequate contraceptive methods during study participation as determined by the Principal Investigator and the study team members

I experience ongoing symptoms like nausea, vomiting, bloating, and abdominal pain due to gastroparesis.

My symptoms are not due to conditions like stomach ulcers or esophagus issues.

Exclusion Criteria

You have high blood sugar, as indicated by a test called HbA1c or fasting blood sugar.

I or someone in my family has had bladder cancer.

I have had surgery on my upper stomach area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive pioglitazone (30 mg po qd) for 8 weeks to evaluate improvement in gastroparesis symptoms

8 weeks

Washout

Participants undergo a washout period to assess the effects of discontinuing pioglitazone

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Pioglitazone

Trial Overview The study is testing if Pioglitazone (30 mg) taken for 8 weeks improves gastroparesis symptoms based on the Gastrointestinal Symptom Index scores. It's designed to see if this treatment helps reduce problems like nausea and abdominal pain in patients without clear causes for their condition.

Participant Groups

Group I: Pioglitazone Experimental Treatment 1 Intervention

Candidates who after the screening period are eligible to receive Pioglitazone

Pioglitazone is already approved in United States for the following indications:

Approved in United States as Actos for:

• Type 2 diabetes mellitus

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment of diabetic gastroparesis with oral domperidone. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Treatment of severely delayed gastric emptying]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Objective and subjective results of a randomized, double-blind, placebo-controlled trial using cisapride to treat gastroparesis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A phase 2a, randomized, double-blind 28-day study of TZP-102 a ghrelin receptor agonist for diabetic gastroparesis. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Gastrokinetic effects of levosulpiride in dyspeptic patients with diabetic gastroparesis. [2022]