Trials / Completed
CompletedNCT01909856
The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Palonosetron | Palonosetron 0.25mg d1,d3 |
| DRUG | Granisetron | Granisetron 3mg d1-3 |
| DRUG | Dexamethasone | Dexamethasone 10mg d1-3 |
| DRUG | Cisplatin | 3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3 |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2014-04-01
- Completion
- 2014-06-01
- First posted
- 2013-07-29
- Last updated
- 2015-12-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01909856. Inclusion in this directory is not an endorsement.