Trial · NCT00787566
Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
NCT00787566, Phase 2, Completed, Shin Nippon Biomedical Laboratories, Ltd.; results first posted 2011-06-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting. Trials, record NCT00787566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00787566
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
- NCT number
- NCT00787566
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 68 participants, actual
- Lead sponsor
- Shin Nippon Biomedical Laboratories, Ltd.
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Interventions
- Intranasal granisetron
- First posted
- 2008-11-07
- Last updated
- 2011-07-12
- Results first posted
- 2011-06-21
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Complete Control | 24 hours | Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale. |
| Secondary | Percentage of Patients With Complete Response | 24 hours | Complete Response is defined as no emetic episodes and no use of rescue medications |
| Secondary | Percentage of Patients With Total Response | 24 hours | Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications |
| Secondary | Percentage of Patients With Major Control of Emesis | 24 hrs | Major Control of emesis = 2 emetic episodes |
| Secondary | Percentage of Patients With Minor Control of Emesis | 24 hrs | Minor Control of emesis: 3-5 emetic episodes |
| Secondary | Percentage of Patients With Failure | 24 hrs | Failure: \> 5 emetic episodes |
| Secondary | Percentage of Patients Using Rescue Medications | 24 hours | |
| Secondary | Time to First Emetic Episode | 24 hours | |
| Secondary | Time to First Rescue Medication | 24 hours | |
| Secondary | Time to Treatment Failure | 24 hours | Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Complete Control | 24 hours | ITT population | Percentage | NUMBER |
| SECONDARY | Percentage of Patients With Complete Response | 24 hours | |||
| SECONDARY | Percentage of Patients With Total Response | 24 hours | |||
| SECONDARY | Percentage of Patients With Major Control of Emesis | 24 hrs | |||
| SECONDARY | Percentage of Patients With Minor Control of Emesis | 24 hrs | |||
| SECONDARY | Percentage of Patients With Failure | 24 hrs | |||
| SECONDARY | Percentage of Patients Using Rescue Medications | 24 hours | |||
| SECONDARY | Time to First Emetic Episode | 24 hours | |||
| SECONDARY | Time to First Rescue Medication | 24 hours | |||
| SECONDARY | Time to Treatment Failure | 24 hours |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Complete Control | 0.5 mg of TRG (Intranasal Granisetron) | 71.4 | Percentage | ||
| Percentage of Patients With Complete Control | 1.0 mg of TRG (Intranasal Granisetron) | 76.0 | Percentage | ||
| Percentage of Patients With Complete Control | 2.0 mg of TRG (Intranasal Granisetron) | 90.9 | Percentage |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.5 mg of TRG (Intranasal Granisetron) | 21 | |
| Overall Study | STARTED | 1.0 mg of TRG (Intranasal Granisetron) | 25 | |
| Overall Study | STARTED | 2.0 mg of TRG (Intranasal Granisetron) | 22 | |
| Overall Study | COMPLETED | 0.5 mg of TRG (Intranasal Granisetron) | 21 | |
| Overall Study | COMPLETED | 1.0 mg of TRG (Intranasal Granisetron) | 24 | |
| Overall Study | COMPLETED | 2.0 mg of TRG (Intranasal Granisetron) | 22 | |
| Overall Study | NOT COMPLETED | 0.5 mg of TRG (Intranasal Granisetron) | 0 | |
| Overall Study | NOT COMPLETED | 1.0 mg of TRG (Intranasal Granisetron) | 1 | |
| Overall Study | NOT COMPLETED | 2.0 mg of TRG (Intranasal Granisetron) | 0 |
Source ClinicalTrials.gov
Adverse events78
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 | Anaemia | Blood and lymphatic system disorders | 0.5 mg of TRG (Intranasal Granisetron) | 0 | 21 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 1.0 mg of TRG (Intranasal Granisetron) | 4 | 25 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | 2.0 mg of TRG (Intranasal Granisetron) | 0 | 22 | 0 |
| other | Anxiety | Psychiatric disorders | 0.5 mg of TRG (Intranasal Granisetron) | 1 | 21 | 1 |
| other | Anxiety | Psychiatric disorders | 1.0 mg of TRG (Intranasal Granisetron) | 2 | 25 | 2 |
| other | Anxiety | Psychiatric disorders | 2.0 mg of TRG (Intranasal Granisetron) | 0 | 22 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 0.5 mg of TRG (Intranasal Granisetron) | 1 | 21 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 1.0 mg of TRG (Intranasal Granisetron) | 2 | 25 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 2.0 mg of TRG (Intranasal Granisetron) | 0 | 22 | 0 |
| other | Constipation | Gastrointestinal disorders | 0.5 mg of TRG (Intranasal Granisetron) | 3 | 21 | 3 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.5 mg of TRG (Intranasal Granisetron) | ||
| Total, all-cause mortality | 1.0 mg of TRG (Intranasal Granisetron) | ||
| Total, all-cause mortality | 2.0 mg of TRG (Intranasal Granisetron) | ||
| Total, other adverse events | 0.5 mg of TRG (Intranasal Granisetron) | 16 | 21 |
| Total, other adverse events | 1.0 mg of TRG (Intranasal Granisetron) | 16 | 25 |
| Total, other adverse events | 2.0 mg of TRG (Intranasal Granisetron) | 15 | 22 |
| Total, serious adverse events | 0.5 mg of TRG (Intranasal Granisetron) | 2 | 21 |
| Total, serious adverse events | 1.0 mg of TRG (Intranasal Granisetron) | 1 | 25 |
| Total, serious adverse events | 2.0 mg of TRG (Intranasal Granisetron) | 1 | 22 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00787566
GET https://conductscience.org/api/trials/v1/NCT00787566/events?page=2