Trial · NCT00601172
A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.
NCT00601172, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-01-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting. Trials, record NCT00601172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00601172
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.
- NCT number
- NCT00601172
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 710 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Nausea and Vomiting, Chemotherapy-Induced
- Interventions
- Casopitant, Dexamethasone, Placebo, Ondansetron
- First posted
- 2008-01-25
- Last updated
- 2018-01-17
- Results first posted
- 2018-01-17
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen | 0 to 120 hours in the first cycle of chemotherapy | Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began at the start of the administration of the oxaliplatin infusion. Percentage of participants who achieved a complete response in the overall phase (0-120 hours) are presented. |
| Secondary | Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1 | 0 to 24 hours in the first cycle of chemotherapy | Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participants who achieved a complete response in the acute phase of Cycle 1 are presented. |
| Secondary | Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1 | 24 to 120 hours (delayed phase) in the first cycle of chemotherapy | Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participants who achieved a complete response in the delayed phase of Cycle 1 are presented. |
| Secondary | Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2 | 0 to 120 hours in the second cycle of chemotherapy | Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began at the start of the administration of the oxaliplatin infusion. Percentage of participants who achieved a complete response in the overall phase of Cycle 2 are presented. |
| Secondary | Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS) | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. |
| Secondary | Percentage of Participants Who Received Rescue Medication | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | Anti-emetic rescue medication was defined as medication that was administered specifically for the treatment of nausea and/or emesis during Days 1-6 of each cycle. The choice of rescue anti-emetic medication was left to the discretion of the investigator. Participants who required antiemetic rescue medication(s) during the 120-hour assessment period were considered treatment failures for that cycle. Percentage of participants who received rescue medication are presented. |
| Secondary | Percentage of Participants Who Vomited and/or Retched | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | Vomiting was defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching was defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit, that is not productive of gastrointestinal contents (also known as dry heaves). If a participant took rescue medication but there was no evidence of vomiting or retching, then the participant was considered as not having vomited. Percentage of participants who vomited and/or retched during the first 120 hours of the first cycle of chemotherapy are presented. |
| Secondary | Percentage of Participants Who Reported Significant Nausea, Defined as a Maximum Score >= 25 mm on the VAS | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported significant nausea, defined as a maximum score \>= 25 mm on the VAS are presented. |
| Secondary | Percentage of Participants Who Reported Nausea, Defined as a Maximum Score of >= 5 mm on the VAS | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported nausea, defined as a maximum score of \>= 5 mm on the VAS are presented. |
| Secondary | Percentage of Participants Who Achieved Complete Protection Defined as Complete Responders With no Significant Nausea | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | Complete protection was defined as no vomiting/retching, no use of rescue medication and no significant nausea. Percentage of participants who achieved complete protection or complete responders with no significant nausea are presented. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen | 0 to 120 hours in the first cycle of chemotherapy | Modified Intent-to-Treat Population (mITT) comprised of all participants who were randomized, received any investigational product and had oxaliplatin administered. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1 | 0 to 24 hours in the first cycle of chemotherapy | MITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1 | 24 to 120 hours (delayed phase) in the first cycle of chemotherapy | MITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2 | 0 to 120 hours in the second cycle of chemotherapy | MITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS) | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | MITT Population. Only those participants available at the specified time points were analyzed. | Scores on a Scale | MEAN |
| SECONDARY | Percentage of Participants Who Received Rescue Medication | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | MITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Vomited and/or Retched | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | MITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Reported Significant Nausea, Defined as a Maximum Score >= 25 mm on the VAS | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | MITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Reported Nausea, Defined as a Maximum Score of >= 5 mm on the VAS | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | MITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Complete Protection Defined as Complete Responders With no Significant Nausea | 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy | MITT Population. | Percentage of participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group236
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen | Placebo | 85 | Percentage of participants | ||
Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen | Casopitant 90 mg | 86 | Percentage of participants | ||
| Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1 | Placebo | 96 | Percentage of participants | ||
| Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1 | Casopitant 90 mg | 97 | Percentage of participants | ||
| Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1 | Placebo | 85 | Percentage of participants | ||
| Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1 | Casopitant 90 mg | 86 | Percentage of participants | ||
| Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2 | Placebo | 84 | Percentage of participants | ||
| Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2 | Casopitant 90 mg | 90 | Percentage of participants | ||
| Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS) | Placebo | 0-120 hours | 13.5 | Standard Deviation 23.3 | Scores on a Scale |
| Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS) | Casopitant 90 mg | 0-120 hours | 16.0 | Standard Deviation 24.5 | Scores on a Scale |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 355 | |
| Overall Study | STARTED | Casopitant 90 mg | 355 | |
| Overall Study | COMPLETED | Placebo | 214 | |
| Overall Study | COMPLETED | Casopitant 90 mg | 228 | |
| Overall Study | NOT COMPLETED | Placebo | 141 | |
| Overall Study | NOT COMPLETED | Casopitant 90 mg | 127 |
Source ClinicalTrials.gov
Adverse events116
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 74 | 352 | |
| other | Diarrhoea | Gastrointestinal disorders | Casopitant 90 mg | 96 | 355 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 74 | 352 | |
| other | Nausea | Gastrointestinal disorders | Casopitant 90 mg | 88 | 355 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 39 | 352 | |
| other | Constipation | Gastrointestinal disorders | Casopitant 90 mg | 38 | 355 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 35 | 352 | |
| other | Vomiting | Gastrointestinal disorders | Casopitant 90 mg | 16 | 355 | |
| other | Stomatitis | Gastrointestinal disorders | Placebo | 22 | 352 | |
| other | Stomatitis | Gastrointestinal disorders | Casopitant 90 mg | 21 | 355 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 5 | 352 |
| Total, all-cause mortality | Casopitant 90 mg | 4 | 355 |
| Total, other adverse events | Placebo | 237 | 352 |
| Total, other adverse events | Casopitant 90 mg | 257 | 355 |
| Total, serious adverse events | Placebo | 23 | 352 |
| Total, serious adverse events | Casopitant 90 mg | 26 | 355 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21822913 | BACKGROUND |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Casopitant 90 mg vs Placebo: deaths from any cause | Trial comparisons |
| Casopitant 90 mg vs 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/NCT00601172
GET https://conductscience.org/api/trials/v1/NCT00601172/registered?page=2