Trial · NCT01149369
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
NCT01149369, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2019-05-08
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ConductScience Library. Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial. Trials, record NCT01149369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01149369
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
- NCT number
- NCT01149369
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Gastroparesis
- Interventions
- Aprepitant, Placebo
- First posted
- 2010-06-23
- Last updated
- 2019-05-08
- Results first posted
- 2019-05-08
Source ClinicalTrials.gov
Registered outcomes80
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Improvement in Nausea | 4 weeks | The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of \< 25 mm. |
| Secondary | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours) | 4 weeks | Measure Description: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours. The outcome measure, change from baseline in number of hours of nausea, has a possible range from -24 to +24, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Secondary | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes) | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours. The outcome is the change from baseleine in number of times vomited, where negative numbers indicate improvement in vomiting frequency, and positive numbers indicate worsening in vomiting frequency. |
| Secondary | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes) | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours. The outcome is the change from baseline in the number of retching episodes, where negative numbers indicate improvement in retching frequency, and positive numbers indicate worsening in retching frequency. |
| Secondary | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score | 4 weeks | The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI total score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Secondary | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Secondary | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Secondary | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Secondary | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity is the participant's assessment of excessive fullness (feeling excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Secondary | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity is the participant's assessment of early satiety (not able to finish normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Early Satiety Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 registered outcomesOutcomes80
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Improvement in Nausea | 4 weeks | participants | NUMBER | |
| SECONDARY | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours) | 4 weeks | The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit. | hours of nausea | MEAN |
| SECONDARY | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes) | 4 weeks | The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit. | number of episodes | MEAN |
| SECONDARY | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes) | 4 weeks | The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit. | number of episodes | MEAN |
| SECONDARY | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score | 4 weeks | The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit. | units on a scale | MEAN |
| SECONDARY | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity | 4 weeks | The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit. | units on a scale | MEAN |
| SECONDARY | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity | 4 weeks | The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit. | units on a scale | MEAN |
| SECONDARY | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity | 4 weeks | The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit. | units on a scale | MEAN |
| SECONDARY | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity | 4 weeks | The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit. | units on a scale | MEAN |
| SECONDARY | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity | 4 weeks | The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit. | units on a scale | MEAN |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 outcomesResults by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Improvement in Nausea | Aprepitant | 29 | participants | ||
| Number of Participants With Improvement in Nausea | Aprepitant-placebo | 25 | participants | ||
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours) | Aprepitant | -2.5 | Standard Deviation 3.2 | hours of nausea | |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours) | Aprepitant-placebo | -1.2 | Standard Deviation 4.3 | hours of nausea | |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes) | Aprepitant | -0.5 | Standard Deviation 1.0 | number of episodes | |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes) | Aprepitant-placebo | -0.4 | Standard Deviation 1.1 | number of episodes | |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes) | Aprepitant | -0.5 | Standard Deviation 1.5 | number of episodes | |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes) | Aprepitant-placebo | -0.7 | Standard Deviation 2.0 | number of episodes | |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score | Aprepitant | -0.5 | Standard Deviation 0.9 | units on a scale | |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score | Aprepitant-placebo | -0.4 | Standard Deviation 0.5 | units on a scale |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aprepitant | 63 | |
| Overall Study | STARTED | Aprepitant-placebo | 63 | |
| Overall Study | COMPLETED | Aprepitant | 57 | |
| Overall Study | COMPLETED | Aprepitant-placebo | 60 | |
| Overall Study | NOT COMPLETED | Aprepitant | 6 | |
| Overall Study | NOT COMPLETED | Aprepitant-placebo | 3 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea, vomiting | Gastrointestinal disorders | Aprepitant | 1 | 63 | 1 |
| other | Nausea, vomiting | Gastrointestinal disorders | Aprepitant-placebo | 1 | 63 | 1 |
| other | Nausea | Gastrointestinal disorders | Aprepitant | 1 | 63 | 1 |
| other | Nausea | Gastrointestinal disorders | Aprepitant-placebo | 2 | 63 | 2 |
| other | Vomiting | Gastrointestinal disorders | Aprepitant | 0 | 63 | 0 |
| other | Vomiting | Gastrointestinal disorders | Aprepitant-placebo | 1 | 63 | 1 |
| other | Flashing lights/floaters | Eye disorders | Aprepitant | 0 | 63 | 0 |
| other | Flashing lights/floaters | Eye disorders | Aprepitant-placebo | 1 | 63 | 1 |
| other | Bruising | Skin and subcutaneous tissue disorders | Aprepitant | 1 | 63 | 1 |
| other | Bruising | Skin and subcutaneous tissue disorders | Aprepitant-placebo | 0 | 63 | 0 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aprepitant | 0 | 63 |
| Total, all-cause mortality | Aprepitant-placebo | 0 | 63 |
| Total, other adverse events | Aprepitant | 21 | 63 |
| Total, other adverse events | Aprepitant-placebo | 11 | 63 |
| Total, serious adverse events | Aprepitant | 1 | 63 |
| Total, serious adverse events | Aprepitant-placebo | 0 | 63 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29111115 | DERIVED |
Source PubMed
Grants7
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01DK073974 | Exploration of Subtypes of Gastroparesis and Gastroparesis-like Symptoms based on Physiological Testing | MOSHIREE, BAHARAK | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2006 to 2025 | NIH RePORTER |
| U01DK073975 | Temple University Gastroparesis Clinical Center | PARKMAN, HENRY PAUL | TEMPLE UNIV OF THE COMMONWEALTH | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2006 to 2025 | NIH RePORTER |
| U01DK073983 | Advancing Science for the Diagnosis and Treatment of Gastroparesis | PASRICHA, PANKAJ J | MAYO CLINIC ARIZONA | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2006 to 2025 | NIH RePORTER |
| U01DK074007 | U of L Clinical Center to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis Consortium | ABELL, THOMAS LYMAN | UNIVERSITY OF LOUISVILLE | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2006 to 2025 | NIH RePORTER |
| U01DK074035 | A multicenter, double-blind, randomized, placebo- controlled, parallel study to assess the efficacy of 5- HT4 agonist prucalopride for the treatment of diabetic and idiopathic gastroparesis | SAROSIEK, IRENE | TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2025 | NIH RePORTER |
| U01DK073985 | Gastroparesis Clinical Research Consortium-University of Michigan Clinical Center | HASLER, WILLIAM L | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2006 to 2015 | NIH RePORTER |
| U01DK074008 | Gastroparesis Consortium Continuation-Data Coordinating Center | TONASCIA, JAMES A | JOHNS HOPKINS UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2006 to 2015 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aprepitant vs Aprepitant-placebo: deaths from any cause | Trial comparisons |
| Aprepitant vs Aprepitant-placebo: Number of Participants With Improvement in Nausea | Trial comparisons |
| Aprepitant vs Aprepitant-placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01149369
GET https://conductscience.org/api/trials/v1/NCT01149369/registered?page=2