JPRN-UMIN000010688
Completed
Phase 2
Random Phase II Study of Effectiveness of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy in the Patients with Gynecologic Malignancy - Random Phase II Study of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy
Kansai Clinical Oncology Group0 sites80 target enrollmentJuly 15, 2013
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Paclitaxel-induced peripheral neuropathy in the patients with gynecological malignancies
- Sponsor
- Kansai Clinical Oncology Group
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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