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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.
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:
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
Sample size justification
Number of clinical centers
• Johns Hopkins Bayview Medical Center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Experimental | Candidates who after the screening period are eligible to receive Pioglitazone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone 30 mg | Drug | Patients will received 30 mg of Pioglitazone once a day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, later monthly up to 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn J Treisman, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone Group | Candidates who are deemed eligible after the screening period will receive Pioglitazone 30 mg once daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| First Intervention - 4 Weeks Treatment |
| |||||||||||||
| Second Intervention - 4 Weeks Treatment |
| |||||||||||||
| Third Intervention - 4 Weeks of Wash Out |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | Candidates who after the screening period are eligible to receive Pioglitazone Pioglitazone 30 mg: Patients will received 30 mg of Pioglitazone once a day for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who started time point are reported | Posted | Mean | Standard Deviation | score on a scale | Baseline, later monthly up to 3 months. |
|
Up to 3.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone | Candidates who after the screening period are eligible to receive Pioglitazone Pioglitazone 30 mg: Patients will received 30 mg of Pioglitazone once a day for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jay Pasricha | Mayo Clinic Arizona | (480)301-4279 | pasricha.jay@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2020 | Apr 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Pilot study
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| 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. | 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. | 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. | 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. | 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. | Baseline, later monthly up to 3 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Participants who started time point are reported | Posted | Mean | Standard Deviation | score on a scale | Baseline and later monthly up to 3 months |
|
|
|
| Secondary | 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. | Participants who started time point are reported | Posted | Mean | Standard Deviation | score on a scale | Baseline, later monthly up to 3 months |
|
|
|
| Secondary | 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. | Participants who started time point are reported | Posted | Mean | Standard Deviation | mg/L | Baseline and 2 months after treatment initiation. |
|
|
|
| Secondary | 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. | Participants who started time point are reported | Posted | Mean | Standard Deviation | mm/h | Baseline and 2 months after treatment initiation |
|
|
|
| Secondary | 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. | Participants who started time point are reported | Posted | Mean | Standard Deviation | score on a scale | Baseline, later monthly up to 3 months |
|
|
|
| Secondary | 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. | Participants who started time point are reported | Posted | Mean | Standard Deviation | score on a scale | Baseline, later monthly up to 3 months |
|
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| 0 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Leucopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Headaches | Nervous system disorders | Systematic Assessment |
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| Muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Vomit | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 2nd month of treatment |
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| 3rd month / washout |
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| Physical Functioning - 2nd month |
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| Physical Functioning - Washout |
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| Role limitations due to physical activity - Baseline |
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| Role limitations due to physical activity - 1st month |
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| Role limitations due to physical activity - 2nd month |
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| Role limitations due to physical activity - 3rd month / Washout |
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| Role limitations due to emotional problems - Baseline |
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| Role limitations due to emotional problems - 1st month |
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| Role limitations due to emotional problems - 2nd month |
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| Role limitations due to emotional problems - 3rd month / Washout |
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| Pain - Baseline |
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| Pain - 1st month |
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| Pain - 2nd month |
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| Pain - 3rd month/Washout |
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| Emotional well being - Baseline |
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| Emotional well being - 1st month |
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| Emotional well being - 2nd month |
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| Emotional well being - 3rd month / Washout |
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| Energy / fatigue - Baseline |
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| Energy / fatigue - 1st month |
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| Energy / fatigue - 2nd month |
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| Energy / fatigue - 3rd month / Washout |
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| Social functioning - Baseline |
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| Social functioning - 1st month |
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| Social functioning - 2nd month |
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| Social functioning - 3rd month / Washout |
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| General health - Baseline |
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| General health - 1st month |
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| General health - 2nd month |
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| General health - 3rd month / Washout |
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| 8 Weeks BDI-II |
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| Washout BDI-II |
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| State Anxiety - 2nd month |
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| State Anxiety - 3rd month / Washout |
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| Trait Anxiety - Baseline |
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| Trait Anxiety - 1st month |
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| Trait Anxiety - 2nd month |
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| Trait Anxiety - 3rd month / Washout |
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