GastroparesisEarly Phase 1PIOGASNCT04300127
Pioglitazone for Idiopathic Gastroparesis
A Early Phase 1 study testing Pioglitazone 30 mg in people with Gastroparesis, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Pioglitazone 30 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 18 Mar 2025
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older at registration
- Diagnosis of gastroparesis as documented by gastric emptying scintigraphy (4-hour emptying after a low-fat meal with any combination of 2 and 4 hour retention of >60% and 10% respectively)
- Ongoing symptoms referable to gastroparesis (i.e. Nausea and vomiting, bloating, and abdominal pain)
- Exclusion of other causes of symptoms such as mechanical gastrointestinal obstruction, uncontrolled esophagitis, peptic ulcer disease, etc. By standard radiographic or endoscopic tests
- Females will be required to use adequate contraceptive methods during study participation as determined by the Principal Investigator and the study team members
Who cannot join
- Another active disorder, which could explain symptoms in the opinion of the investigator
- Age < than 18 years
- Pregnancy or nursing
- Previous surgery of the upper gastrointestinal tract, including vagotomy
- Another active disorder, which could explain symptoms in the opinion of the investigator
- Use of narcotics more than 3 days per week
Show all 14Show fewer
- Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2 x upper limit of normal (ULN) or a Child-Pugh score of 10 or greater
- Serious systemic disease, such as recent myocardial infarction/unstable angina, decompensated congestive heart failure, severe pulmonary disease with dyspnea at rest, or altered mental status from any cause
- Diabetes as defined by HbA1c >6.5 and/or fasting blood sugar of >125 mg/DL
- Contraindications to pioglitazone such as hypersensitivity or allergy
- Concurrent use of: estradiol, ethynyl estradiol, mestranol, pazopanib, warfarin, digoxin, atorvastatin, ranitidine, gemfibrozil, fexofenadine, midazolam
- Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
- History of bladder cancer or family history of bladder cancer
- Failure to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Pioglitazone for the Treatment of Idiopathic Gastroparesis (PIOGAS Study)
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.
Read the detailed 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 23 patients
- Primary comparison: Baseline PAGI-SYM score versus 4, 8, and 12 weeks.
Number of clinical centers
- Johns Hopkins Bayview Medical Center.
- Conditions
- Gastroparesis
- Being tested
- Pioglitazone 30 mg
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone 30 mgDrug
Patients will received 30 mg of Pioglitazone once a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Candidates who after the screening period are eligible to receive Pioglitazone Receives: Drug: Pioglitazone 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index
The effect of Pioglitazone on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index (GCSI) which has been designed to assess symptoms associated with gastroparesis. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours. Values reported represent the mean participant scale choice.
Measured: Baseline, later monthly up to 3 months.
Secondary outcomes (6)
Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
The Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM) questionnaire is a patient-reported tool designed to evaluate the severity of upper gastrointestinal symptoms across multiple domains, including nausea/vomiting, postprandial fullness/early satiety, bloating, upper abdominal pain, and heartburn/regurgitation. Each symptom is rated on a 0 to 5 Likert scale, where 0 indicates no symptoms and 5 represents very severe symptoms, with higher scores reflecting worse symptom severity. The total PAGI-SYM score is typically calculated as the average of individual domain scores, resulting in a possible score range of 0 to 5. The mean participant scale choice is reported.
Measured: Baseline and later monthly up to 3 months
Functional Status as Assessed by the SF-36v2 Health Survey
The effect of Pioglitazone on quality of life assessed by the SF-36v2 Health Survey. The SF-36v2 is a 36-item, self-report measure designed to assess quality of life in patients. This measure also provides two summary scores (physical and mental health) and eight scale scores. The eight sections are: vitality, physical functioning, bodily pain and general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, later monthly up to 3 months
C- Reactive Protein Level in Blood
The effect of Pioglitazone on Inflammatory markers as per changes in the values of C reactive protein (CRP) in blood. Normal CRP levels are below 3.0 mg/L.
Measured: Baseline and 2 months after treatment initiation.
Erythrocyte Sedimentation Rate (ESR)
The effect of Pioglitazone on Inflammatory markers as per changes Erythrocyte Sedimentation Rate (ESR) in blood. Results are reported as the millimeters of clear fluid (plasma) that are present at the top portion of the tube after one hour. The normal range is 0 to 22 mm/hr for men and 0 to 29 mm/hr for women. Values above these ranges are considered worse.
Measured: Baseline and 2 months after treatment initiation
Mood as Assessed by the Beck Depression Inventory
The effect of Pioglitazone on mood as per changes in the score of Beck Depression Inventory (BDI-II). The BDI-II is a commonly used, reliable 21-item self-report measure designed to assess for depression. Individuals are asked to respond to each question based on a two-week time period. The BDI-II is widely used as an indicator of the severity of depression, but not as a diagnostic tool. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on the severity of each item. The maximum total score range is 0-63. Higher total scores indicate more severe depressive symptoms.
Measured: Baseline, later monthly up to 3 months
Mood as Assessed by the State-Trait Anxiety Inventory
The effect of Pioglitazone on mood as per changes in the score of the State-Trait Anxiety Inventory (STAI). The STAI is a 40-item self-report measure designed to assess anxiety. This measure provides two subscale scores (State and Trait). STAI is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: Baseline, later monthly up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start24 Oct 2019
- Primary completion15 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn J Treisman, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300127
- Sponsor's protocol ID
- IRB00184232
- Acronym
- PIOGAS
- Status last verified
- Apr 2025
- First submitted
- 5 Mar 2020
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pioglitazone for the Treatment of Idiopathic Gastroparesis (PIOGAS Study)
- ClinicalTrials.gov ID
- NCT04300127
- Acronym / sponsor ID
- PIOGAS / IRB00184232
- Conditions
- Gastroparesis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 23 patients
- Primary comparison: Baseline PAGI-SYM score versus 4, 8, and 12 weeks.
Number of clinical centers
- Johns Hopkins Bayview Medical Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: Pioglitazone 30 mgCandidates who after the screening period are eligible to receive Pioglitazone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older at registration
- Diagnosis of gastroparesis as documented by gastric emptying scintigraphy (4-hour emptying after a low-fat meal with any combination of 2 and 4 hour retention of >60% and 10% respectively)
- Ongoing symptoms referable to gastroparesis (i.e. Nausea and vomiting, bloating, and abdominal pain)
- Exclusion of other causes of symptoms such as mechanical gastrointestinal obstruction, uncontrolled esophagitis, peptic ulcer disease, etc. By standard radiographic or endoscopic tests
- Females will be required to use adequate contraceptive methods during study participation as determined by the Principal Investigator and the study team members
Key exclusion criteria (14 listed)
- Another active disorder, which could explain symptoms in the opinion of the investigator
- Age < than 18 years
- Pregnancy or nursing
- Previous surgery of the upper gastrointestinal tract, including vagotomy
- Another active disorder, which could explain symptoms in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone 30 mgPatients will received 30 mg of Pioglitazone once a day for 8 weeks | Drug | Pioglitazone |
Primary outcome
Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index
Time frame: Baseline, later monthly up to 3 months.
The effect of Pioglitazone on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index (GCSI) which has been designed to assess symptoms associated with gastroparesis. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours. Values reported represent the mean participant scale choice.
6 secondary outcomes
Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Time frame: Baseline and later monthly up to 3 months
Functional Status as Assessed by the SF-36v2 Health Survey
Time frame: Baseline, later monthly up to 3 months
C- Reactive Protein Level in Blood
Time frame: Baseline and 2 months after treatment initiation.
Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and 2 months after treatment initiation
Mood as Assessed by the Beck Depression Inventory
Time frame: Baseline, later monthly up to 3 months
Mood as Assessed by the State-Trait Anxiety Inventory
Time frame: Baseline, later monthly up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn J Treisman, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pioglitazone 30 mg in people with Gastroparesis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index (time frame: Baseline, later monthly up to 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.