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This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is <3 months, and the planned sample size was 170 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| granisetron | Drug | 20 micrograms intravenously (iv) 15 min prior to end of surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With no Vomiting | Number of patients with no vomiting is described as no emesis up to 2 hours after surgery | 0-2h after end of surgery (time of extubation) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With no Vomiting | No vomiting describes no emesis during the first 24 hours | 0-24h after time of extubation |
| Time to First Vomiting Episode | Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresno | California | 93720 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Granisetron 20 ug/kg | Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery |
| FG001 | Granisetron 40 ug/kg | Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| granisetron | Drug | 40 micrograms intravenously (iv) 15 min prior to end of surgery |
|
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| 0-24h after time of extubation |
| Adverse Experiences | The adverse events are captured in the AE and SAE section of this database | infusion to 15 days post treatment |
| Stanford |
| California |
| 94305-5118 |
| United States |
| Hartford | Connecticut | 06106 | United States |
| Miami | Florida | 33136 | United States |
| Atlanta | Georgia | 30322 | United States |
| Indianapolis | Indiana | 46223 | United States |
| Baltimore | Maryland | 21287 | United States |
| Boston | Massachusetts | 02114 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Nashville | Tennessee | 37232 | United States |
| Dallas | Texas | 75235 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Granisetron 20 ug/kg | Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery |
| BG001 | Granisetron 40 ug/kg | Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The safety population was all evaluable population. The evaluable population consisted of 143 pediatric subjects from 2 to 16 years. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With no Vomiting | Number of patients with no vomiting is described as no emesis up to 2 hours after surgery | Evaluable Patients | Posted | Number | participants | 0-2h after end of surgery (time of extubation) |
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| Secondary | Number of Patients With no Vomiting | No vomiting describes no emesis during the first 24 hours | Evaluable Patients | Posted | Number | participants | 0-24h after time of extubation |
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| Secondary | Time to First Vomiting Episode | Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up. | Evaluable Patients | Posted | Mean | Standard Error | hours | 0-24h after time of extubation |
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| Secondary | Adverse Experiences | The adverse events are captured in the AE and SAE section of this database | Eight of the 157 treated subjects (six and two in the 20- and 40-μg/kg dose groups,respectively) experienced a treatment-emergent serious adverse event up to 15 days after the treatment evaluation period. | Posted | Number | Number of participants assessed | infusion to 15 days post treatment |
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Infusion to 15 days post treatment
Eight of the 157 treated subjects (six and two in the 20- and 40-μg/kg dose groups,respectively) experienced a treatment-emergent serious adverse event up to 15 days after the treatment evaluation period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Granisetron 20 ug/kg | Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery | 6 | 79 | 6 | 79 | ||
| EG001 | Granisetron 40 ug/kg | Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery | 2 | 78 | 4 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dehydration | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| migraine | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| oral intake reduced | General disorders | MedDRA (11.0) | Systematic Assessment |
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| post procedural haemorrhage | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
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| oxygen saturation reduced | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| procedural pain | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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"The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights."
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017829 | Granisetron |
| ID | Term |
|---|---|
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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