Clinical trial for testing the drug fosaprepitant for its effectiveness in preventing nausea and vomiting in childre
Phase 3
Completed
- Conditions
- Health Condition 1: C00-D49- NeoplasmsHealth Condition 2: null- Pediatric cancer patients undergoing chemotherapy
- Registration Number
- CTRI/2017/02/007925
- Lead Sponsor
- Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 164
Inclusion Criteria
1. Patient is 1 to 12 years of age at time of study entry.
2. Weight less than 30 kg.
3. Parent/guardian (legally authorized representative) agrees to the patientâ??s participation as indicated by parent/legal guardian signature on the informed consent form.
4. Patient is scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for a documented malignancy.
5. Patient >10 years of age has a Karnofsky score >=60; patient <=10 years of age has a Lansky Play Performance score >=60.
6. Patient has a predicted life expectancy of >=3 months.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome :- proportion of patients who achieved a complete response (defined as no vomiting, no retching, and no use of rescue medication) during the 25â??120 h (delayed phase) after initiation of emetogenic chemotherapy <br/ ><br>Timepoint: 24 hours from administration of drug to 7 days
- Secondary Outcome Measures
Name Time Method Secondary outcome:- proportion of patients who achieved complete response during the acute (0â??24 h) and overall phases. (0â??120 h), and no vomiting (regardless of rescue medication use) during the acute, delayed, and overall phases <br/ ><br>Timepoint: from administration of drug to 7 days