Random Phase II Study of Effectiveness of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy in the Patients with Gynecologic Malignancy
Phase 2
- Conditions
- Paclitaxel-induced peripheral neuropathy in the patients with gynecological malignancies
- Registration Number
- JPRN-UMIN000010688
- Lead Sponsor
- Kansai Clinical Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1.ECOG performance status: 3 or 4 2.Patients with neuropathy due to apparently other causes such as diabetes 3.Patients who have received more than two previous chemotherapy regimen 4.Patients with moderate to severe renal dysfunction (serum creatinine >1.5mg/ml, or creatinine clearance <30ml/min) 5.Patients with severe congestive heart failure 6.Patients with angioedema 7.Patients who have been administered laftidine or pregabalin previously for peripheral neuropathy 8.Patients taking any antidepressants or any anticonvulsants 9.Patients for whom completion of this study is deemed inappropriate for any reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Adverse event Feasibility