Trial Outcomes & Findings for Pioglitazone for Idiopathic Gastroparesis (NCT NCT04300127)
NCT ID: NCT04300127
Last Updated: 2025-04-30
Results Overview
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.
COMPLETED
EARLY_PHASE1
14 participants
Baseline, later monthly up to 3 months.
2025-04-30
Participant Flow
Participant milestones
| Measure |
Pioglitazone Group
Candidates who are deemed eligible after the screening period will receive Pioglitazone 30 mg once daily for 8 weeks.
|
|---|---|
|
Baseline
STARTED
|
14
|
|
Baseline
COMPLETED
|
14
|
|
Baseline
NOT COMPLETED
|
0
|
|
First Intervention - 4 Weeks Treatment
STARTED
|
14
|
|
First Intervention - 4 Weeks Treatment
COMPLETED
|
12
|
|
First Intervention - 4 Weeks Treatment
NOT COMPLETED
|
2
|
|
Second Intervention - 4 Weeks Treatment
STARTED
|
12
|
|
Second Intervention - 4 Weeks Treatment
COMPLETED
|
12
|
|
Second Intervention - 4 Weeks Treatment
NOT COMPLETED
|
0
|
|
Third Intervention - 4 Weeks of Wash Out
STARTED
|
12
|
|
Third Intervention - 4 Weeks of Wash Out
COMPLETED
|
12
|
|
Third Intervention - 4 Weeks of Wash Out
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pioglitazone for Idiopathic Gastroparesis
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=14 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.31 years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, later monthly up to 3 months.Population: Participants who started time point are reported
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.
Outcome measures
| Measure |
Pioglitazone Group
n=14 Participants
Candidates who are deemed eligible after the screening period will receive Pioglitazone 30 mg once daily for 8 weeks.
|
|---|---|
|
Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index
Baseline
|
2.9 score on a scale
Standard Deviation 0.9
|
|
Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index
1st month of treatment
|
2.3 score on a scale
Standard Deviation 1.1
|
|
Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index
2nd month of treatment
|
2.2 score on a scale
Standard Deviation 1.1
|
|
Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index
3rd month / washout
|
2.6 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and later monthly up to 3 monthsPopulation: Participants who started time point are reported
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.
Outcome measures
| Measure |
Pioglitazone Group
n=14 Participants
Candidates who are deemed eligible after the screening period will receive Pioglitazone 30 mg once daily for 8 weeks.
|
|---|---|
|
Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Baseline
|
2.6 score on a scale
Standard Deviation 0.9
|
|
Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
1st month of treatment
|
1.9 score on a scale
Standard Deviation 0.9
|
|
Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
2nd month of treatment
|
1.9 score on a scale
Standard Deviation 0.9
|
|
Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
3rd month / washout
|
2.3 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, later monthly up to 3 monthsPopulation: Participants who started time point are reported
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.
Outcome measures
| Measure |
Pioglitazone Group
n=14 Participants
Candidates who are deemed eligible after the screening period will receive Pioglitazone 30 mg once daily for 8 weeks.
|
|---|---|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Pain - 1st month
|
45.2 score on a scale
Standard Deviation 23.7
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Physical Functioning - Baseline
|
54.3 score on a scale
Standard Deviation 17.6
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Physical Functioning - Washout
|
64.6 score on a scale
Standard Deviation 22.1
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Role limitations due to physical activity - Baseline
|
40.2 score on a scale
Standard Deviation 18.6
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Role limitations due to physical activity - 1st month
|
51.3 score on a scale
Standard Deviation 23.2
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Role limitations due to physical activity - 2nd month
|
60.4 score on a scale
Standard Deviation 27.2
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Role limitations due to physical activity - 3rd month / Washout
|
47.2 score on a scale
Standard Deviation 30.9
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Role limitations due to emotional problems - Baseline
|
65.5 score on a scale
Standard Deviation 29.9
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Role limitations due to emotional problems - 1st month
|
68.5 score on a scale
Standard Deviation 30.3
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Role limitations due to emotional problems - 2nd month
|
77.8 score on a scale
Standard Deviation 25.5
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Role limitations due to emotional problems - 3rd month / Washout
|
68.9 score on a scale
Standard Deviation 30.9
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Pain - Baseline
|
62.9 score on a scale
Standard Deviation 19.3
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Pain - 2nd month
|
41.7 score on a scale
Standard Deviation 21.3
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Pain - 3rd month/Washout
|
48.5 score on a scale
Standard Deviation 23.9
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Emotional well being - Baseline
|
46 score on a scale
Standard Deviation 8.1
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Emotional well being - 2nd month
|
48.7 score on a scale
Standard Deviation 9.8
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Emotional well being - 3rd month / Washout
|
46.9 score on a scale
Standard Deviation 11
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Energy / fatigue - Baseline
|
35.7 score on a scale
Standard Deviation 7.3
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Energy / fatigue - 1st month
|
33.6 score on a scale
Standard Deviation 17.4
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Energy / fatigue - 2nd month
|
35.4 score on a scale
Standard Deviation 9.2
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Energy / fatigue - 3rd month / Washout
|
35.5 score on a scale
Standard Deviation 7.6
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Social functioning - Baseline
|
51.8 score on a scale
Standard Deviation 6.7
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Social functioning - 1st month
|
48.2 score on a scale
Standard Deviation 6.7
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Social functioning - 3rd month / Washout
|
50 score on a scale
Standard Deviation 5.6
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
General health - Baseline
|
63.6 score on a scale
Standard Deviation 9.1
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
General health - 1st month
|
55.7 score on a scale
Standard Deviation 20.7
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
General health - 2nd month
|
60.8 score on a scale
Standard Deviation 10.6
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
General health - 3rd month / Washout
|
63.2 score on a scale
Standard Deviation 7.2
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Physical Functioning - 2nd month
|
67.1 score on a scale
Standard Deviation 24.1
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Physical Functioning - 1st month
|
64.6 score on a scale
Standard Deviation 20.0
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Emotional well being - 1st month
|
45.7 score on a scale
Standard Deviation 20.4
|
|
Functional Status as Assessed by the SF-36v2 Health Survey
Social functioning - 2nd month
|
52.1 score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline and 2 months after treatment initiation.Population: Participants who started time point are reported
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.
Outcome measures
| Measure |
Pioglitazone Group
n=14 Participants
Candidates who are deemed eligible after the screening period will receive Pioglitazone 30 mg once daily for 8 weeks.
|
|---|---|
|
C- Reactive Protein Level in Blood
Baseline CRP
|
2.5 mg/L
Standard Deviation 3.9
|
|
C- Reactive Protein Level in Blood
8 weeks CRP
|
5.1 mg/L
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline and 2 months after treatment initiationPopulation: Participants who started time point are reported
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.
Outcome measures
| Measure |
Pioglitazone Group
n=14 Participants
Candidates who are deemed eligible after the screening period will receive Pioglitazone 30 mg once daily for 8 weeks.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR)
Baseline ESR
|
14.5 mm/h
Standard Deviation 20.3
|
|
Erythrocyte Sedimentation Rate (ESR)
2 Months ESR
|
14.8 mm/h
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Baseline, later monthly up to 3 monthsPopulation: Participants who started time point are reported
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.
Outcome measures
| Measure |
Pioglitazone Group
n=14 Participants
Candidates who are deemed eligible after the screening period will receive Pioglitazone 30 mg once daily for 8 weeks.
|
|---|---|
|
Mood as Assessed by the Beck Depression Inventory
Baseline BDI-II
|
17.9 score on a scale
Standard Deviation 11.8
|
|
Mood as Assessed by the Beck Depression Inventory
4 Weeks BDI-II
|
8.6 score on a scale
Standard Deviation 8.2
|
|
Mood as Assessed by the Beck Depression Inventory
8 Weeks BDI-II
|
8.8 score on a scale
Standard Deviation 7.4
|
|
Mood as Assessed by the Beck Depression Inventory
Washout BDI-II
|
12.6 score on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Baseline, later monthly up to 3 monthsPopulation: Participants who started time point are reported
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.
Outcome measures
| Measure |
Pioglitazone Group
n=14 Participants
Candidates who are deemed eligible after the screening period will receive Pioglitazone 30 mg once daily for 8 weeks.
|
|---|---|
|
Mood as Assessed by the State-Trait Anxiety Inventory
State Anxiety - 1st month
|
35.8 score on a scale
Standard Deviation 13.9
|
|
Mood as Assessed by the State-Trait Anxiety Inventory
Trait Anxiety - 1st month
|
33.9 score on a scale
Standard Deviation 15.6
|
|
Mood as Assessed by the State-Trait Anxiety Inventory
Trait Anxiety - 2nd month
|
38.4 score on a scale
Standard Deviation 11.2
|
|
Mood as Assessed by the State-Trait Anxiety Inventory
Trait Anxiety - 3rd month / Washout
|
39.7 score on a scale
Standard Deviation 13
|
|
Mood as Assessed by the State-Trait Anxiety Inventory
State Anxiety - Baseline
|
44.1 score on a scale
Standard Deviation 12.8
|
|
Mood as Assessed by the State-Trait Anxiety Inventory
State Anxiety - 2nd month
|
38.7 score on a scale
Standard Deviation 15
|
|
Mood as Assessed by the State-Trait Anxiety Inventory
State Anxiety - 3rd month / Washout
|
36.8 score on a scale
Standard Deviation 18.2
|
|
Mood as Assessed by the State-Trait Anxiety Inventory
Trait Anxiety - Baseline
|
43.3 score on a scale
Standard Deviation 14.2
|
Adverse Events
Pioglitazone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pioglitazone
n=14 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 1 • Up to 3.5 months
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Number of events 1 • Up to 3.5 months
|
|
Blood and lymphatic system disorders
Leucopenia
|
7.1%
1/14 • Number of events 1 • Up to 3.5 months
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Up to 3.5 months
|
|
Nervous system disorders
Headaches
|
7.1%
1/14 • Number of events 1 • Up to 3.5 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
7.1%
1/14 • Number of events 1 • Up to 3.5 months
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Up to 3.5 months
|
|
Nervous system disorders
Lightheadedness
|
7.1%
1/14 • Number of events 1 • Up to 3.5 months
|
|
Gastrointestinal disorders
Vomit
|
7.1%
1/14 • Number of events 1 • Up to 3.5 months
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 2 • Up to 3.5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place