What side effects are associated with this type of intervention?

Common treatments for gastroparesis include prokinetic agents like metoclopramide and erythromycin, as well as thiazolidinediones like pioglitazone. Metoclopramide can cause side effects such as tardive dyskinesia, drowsiness, and fatigue. Erythromycin may lead to gastrointestinal disturbances, including nausea, vomiting, and abdominal pain. Pioglitazone, while primarily used to improve insulin sensitivity, can cause weight gain, peripheral edema, and an increased risk of fractures. These side effects should be carefully considered when choosing a treatment plan for gastroparesis.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of gastroparesis, primarily focusing on prokinetics to enhance gastric motility. Metoclopramide is the first-line treatment, known for its dopamine antagonist properties that stimulate gastric emptying. Domperidone and erythromycin are also used, with domperidone acting similarly to metoclopramide but with fewer central nervous system side effects, and erythromycin functioning as a motilin receptor agonist. While pioglitazone, a PPAR-γ agonist, is being studied for its potential benefits in improving insulin sensitivity and gastrointestinal motility, it is not yet FDA-approved for gastroparesis. Other investigational agents include relamorelin, a ghrelin receptor agonist, and velusetrag, a 5HT-4 receptor agonist, which are still under clinical evaluation.

What other types of research exist?

Promising novel alternatives to Pioglitazone for gastroparesis include Velusetrag, which has shown significant efficacy in accelerating gastric emptying in clinical trials, and GLP-1 receptor agonists like Exenatide, which have been studied for their effects on gastric emptying in diabetic patients. Additionally, the use of prokinetic agents such as Buspirone has been explored for functional dyspepsia, which may have implications for gastroparesis treatment.

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Thiazolidinedione

Pioglitazone for Gastroparesis (PIOGAS Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for gastroparesis work by enhancing gastric motility and improving gastric emptying. Prokinetic agents like erythromycin stimulate motilin receptors, while cisapride acts on serotonin receptors to increase gastric muscle contractions. Gastric electrical stimulation and endoscopic pyloromyotomy modulate gastric muscle activity to facilitate better gastric emptying. Pioglitazone, which activates PPAR-γ, improves insulin sensitivity and may also enhance gastrointestinal motility. These mechanisms are important for gastroparesis patients as they help in selecting appropriate treatments to alleviate symptoms and improve quality of life.

Phase < 1

Waitlist Available

Led By Glenn J Treisman, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older at registration

Ongoing symptoms referable to gastroparesis (i.e. Nausea and vomiting, bloating, and abdominal pain)

Must not have

History of bladder cancer or family history of bladder cancer

Previous surgery of the upper gastrointestinal tract, including vagotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Pioglitazone may cause side effects such as fluid retention leading to swelling and weight gain; potential increase in risk of bladder cancer; heart failure; anemia; fatigue; headache; sinus irritation/infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I have been diagnosed with gastroparesis confirmed by a specific stomach test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I or someone in my family has had bladder cancer.

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I have had surgery on my upper stomach area.

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I am not allergic to pioglitazone.

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I do not have severe heart, lung problems, or mental health issues.

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I am currently taking medications like warfarin, digoxin, or atorvastatin.

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My liver tests are much higher than normal or my liver function is severely impaired.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Severity of gastrointestinal symptoms as assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary

Secondary study objectives

Change in Behavior as assessed by the Beck Depression Inventory

Change in Behavior as assessed by the State-Trait Anxiety Inventory

Change in C- reactive protein level in blood

+5 more

Side effects data

From 2013 Phase 3 trial • 936 Patients • NCT01183013

Oedema peripheral

Nasopharyngitis

Hyperglycaemia

Urinary tract infection

Headache

Dizziness

Upper respiratory tract infection

Arthralgia

Back pain

Pain in extremity

Bronchitis

Hypertension

Retinal artery embolism

Myocardial infarction

Constipation

Congestive cardiomyopathy

Gastrointestinal haemorrhage

Appendicitis

Basal cell carcinoma

Renal cell carcinoma

Sleep apnoea syndrome

Oedema

Acute myocardial infarction

100%

80%

60%

40%

20%

Study treatment Arm

Pio30/Pio30

Lina5Pio45/Lina5Pio45

Lina5/Lina5

Pio15/Pio30

Pio45/Pio45

Lina5Pio15/Lina5Pio30

Lina5Pio30/Lina5Pio30

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PioglitazoneExperimental Treatment1 Intervention

Candidates who after the screening period are eligible to receive Pioglitazone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pioglitazone 30 mg

2021

Completed Phase 4

~1770

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastroparesis work by enhancing gastric motility and improving gastric emptying. Prokinetic agents like erythromycin stimulate motilin receptors, while cisapride acts on serotonin receptors to increase gastric muscle contractions. Gastric electrical stimulation and endoscopic pyloromyotomy modulate gastric muscle activity to facilitate better gastric emptying. Pioglitazone, which activates PPAR-γ, improves insulin sensitivity and may also enhance gastrointestinal motility. These mechanisms are important for gastroparesis patients as they help in selecting appropriate treatments to alleviate symptoms and improve quality of life.

Velusetrag accelerates gastric emptying in subjects with gastroparesis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 study.Effect of Pistacia atlantica kurdica gum on diabetic gastroparesis symptoms: a randomized, triple-blind placebo-controlled clinical trial.