Your session is about to expire
← Back to Search
Thiazolidinedione
Pioglitazone for Gastroparesis (PIOGAS Trial)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily up to 3 months
Awards & highlights
PIOGAS Trial Summary
This trial will test whether the drug pioglitazone can improve symptoms of idiopathic gastroparesis, as measured by the Gastrointestinal Symptom Index.
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.Check my eligibility
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.See study design
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.
PIOGAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I experience ongoing symptoms like nausea, vomiting, bloating, and abdominal pain due to gastroparesis.
Select...
I have been diagnosed with gastroparesis confirmed by a specific stomach test.
PIOGAS Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Severity of gastrointestinal symptoms as assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary
Secondary outcome measures
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 moreSide effects data
From 2013 Phase 3 trial • 936 Patients • NCT0118301310%
Oedema peripheral
9%
Hypertension
9%
Back pain
7%
Nasopharyngitis
7%
Hyperglycaemia
5%
Urinary tract infection
5%
Headache
4%
Pain in extremity
4%
Bronchitis
3%
Oedema
2%
Diarrhoea
2%
Arthralgia
2%
Upper respiratory tract infection
1%
Pneumothorax
1%
Pancreatitis acute
1%
Rectosigmoid cancer
1%
Hairy cell leukaemia
1%
Jaundice
1%
Myocardial infarction
1%
Intestinal haemorrhage
1%
Pneumonia
1%
Small intestine carcinoma
1%
Bipolar disorder
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pio15/Pio30
Pio30/Pio30
Pio45/Pio45
Lina5/Lina5
Lina5Pio15/Lina5Pio30
Lina5Pio30/Lina5Pio30
Lina5Pio45/Lina5Pio45
PIOGAS 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
~1670
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,643 Total Patients Enrolled
11 Trials studying Gastroparesis
1,218 Patients Enrolled for Gastroparesis
Glenn J Treisman, MDPrincipal InvestigatorJohns Hopkins University
Pankaj J Pasricha, MDPrincipal InvestigatorJohns Hopkins University
8 Previous Clinical Trials
1,399 Total Patients Enrolled
4 Trials studying Gastroparesis
1,093 Patients Enrolled for Gastroparesis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am not allergic to pioglitazone.I am 18 years old or older.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.I do not have severe heart, lung problems, or mental health issues.I am currently taking medications like warfarin, digoxin, or atorvastatin.I have been diagnosed with gastroparesis confirmed by a specific stomach test.My liver tests are much higher than normal or my liver function is severely impaired.I am under 18 years old.You take strong pain medication more than 3 days a week.You have another medical condition that could be causing your symptoms, according to the doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Pioglitazone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants to join in this trial?
"This clinical trial, which was first posted on October 24th 2019 and updated most recently on March 8th 2022 is actively looking to enroll participants. Data from clinicaltrials.gov confirms this information."
Answered by AI
Are there any documented precedents of Pioglitazone 30 mg being trialed previously?
"Currently, 31 trials are being conducted for research into Pioglitazone 30 mg. Of these studies, 4 have reached Phase 3. Most of the clinical tests take place in Lausanne, Vaud; yet there are 69 sites where experiments involving this pharmaceutical can be found."
Answered by AI
How many participants have joined this trial's cohort?
"Affirmative. According to clinicaltrials.gov, enrollment is still open for this medical trial which was first posted on October 24th 2019 and last updated on March 8th 2022. The study requires the recruitment of 10 individuals across one location."
Answered by AI
For what medical maladies is Pioglitazone 30 mg usually prescribed?
"Pioglitazone 30 mg is a powerful treatment for diabetes, diabetic neuralgia, and dietary issues."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Mississippi
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins Bayview Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Johns Hopkins Bayview Medical Center: < 48 hours
Average response time
- < 2 Days
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger