Trial · NCT00880191
Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
NCT00880191, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2015-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy. Trials, record NCT00880191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00880191
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
- NCT number
- NCT00880191
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 430 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- dexamethasone, gabapentin, placebo
- First posted
- 2009-04-13
- Last updated
- 2016-07-06
- Results first posted
- 2015-05-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Percentage of Complete Responders | Days 2 through 6 | Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder. |
| Secondary | Complete Response | Days 2-6 | The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents. |
| Secondary | Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6. | Days 1 through 6 | The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder. |
| Secondary | Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents | Days1 through 6 | The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups. |
| Secondary | Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses | Days 1 through 6 | The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared. |
| Secondary | Level of Satisfaction for the Control of Nausea. | Days 1 through 6 | Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index - Emesis (FLIE) questionnaire ( 1-7 scale, lower the better) |
| Secondary | Comparison of Daily Complete Response Endpoints | Days 1 through 6 | Daily complete response is defined as no emetic episodes and no use of rescue therapy. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of Percentage of Complete Responders | Days 2 through 6 | percentage of participants | NUMBER | |
| SECONDARY | Complete Response | Days 2-6 | percentage of participants | NUMBER | |
| SECONDARY | Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6. | Days 1 through 6 | percentage of participants | NUMBER | |
| SECONDARY | Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents | Days1 through 6 | percentage of participants | NUMBER | |
| SECONDARY | Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses | Days 1 through 6 | units on a scale | MEAN | |
| SECONDARY | Level of Satisfaction for the Control of Nausea. | Days 1 through 6 | 203 patients in Gabapentin arm and 201 patients in Placebo arm submitted the data for this endpoint. | units on a scale | MEAN |
| SECONDARY | Comparison of Daily Complete Response Endpoints | Days 1 through 6 | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of Percentage of Complete Responders | Gabapentin | Response Days 2-6: No | 53.1 | percentage of participants | |
| Comparison of Percentage of Complete Responders | Placebo | Response Days 2-6: No | 59.2 | percentage of participants | |
| Comparison of Percentage of Complete Responders | Gabapentin | Response Days 2-6: Yes | 46.9 | percentage of participants | |
| Comparison of Percentage of Complete Responders | Placebo | Response Days 2-6: Yes | 40.8 | percentage of participants | |
| Complete Response | Gabapentin | Response Days 2-6: No | 56 | percentage of participants | |
| Complete Response | Placebo | Response Days 2-6: No | 60.7 | percentage of participants | |
| Complete Response | Gabapentin | Response Days 2-6: Yes | 44 | percentage of participants | |
| Complete Response | Placebo | Response Days 2-6: Yes | 39.3 | percentage of participants | |
| Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6. | Gabapentin | Response Day 1: No | 32.4 | percentage of participants | |
| Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6. | Placebo | Response Day 1: No | 33.5 | percentage of participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gabapentin | 207 | |
| Overall Study | STARTED | Placebo | 206 | |
| Overall Study | Available for Primary Endpoint Analysis | Gabapentin | 207 | |
| Overall Study | Available for Primary Endpoint Analysis | Placebo | 206 | |
| Overall Study | COMPLETED | Gabapentin | 194 | |
| Overall Study | COMPLETED | Placebo | 198 | |
| Overall Study | NOT COMPLETED | Gabapentin | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events74
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 | Febrile neutropenia | Blood and lymphatic system disorders | Gabapentin | 0 | 207 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo | 1 | 206 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Gabapentin | 1 | 207 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 206 | 0 |
| other | Vision blurred | Eye disorders | Gabapentin | 1 | 207 | 1 |
| other | Vision blurred | Eye disorders | Placebo | 0 | 206 | 0 |
| other | Constipation | Gastrointestinal disorders | Gabapentin | 2 | 207 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 206 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Gabapentin | 3 | 207 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 206 | 1 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Gabapentin | 95 | 207 |
| Total, other adverse events | Placebo | 96 | 206 |
| Total, serious adverse events | Gabapentin | 0 | 207 |
| Total, serious adverse events | Placebo | 0 | 206 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Gabapentin vs Placebo: serious adverse events |
Source 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/NCT00880191
GET https://conductscience.org/api/trials/v1/NCT00880191/results?page=2