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 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010688

Enrollment

Registered

2013-07-15

Start date

2013-11-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paclitaxel-induced peripheral neuropathy in the patients with gynecological malignancies

Interventions

Administration of lafutidine (oral) Administration of pregabalin (oral)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with gynecological malignancies (cancer in the ovary, peritoneum, tube, cervix, or endometrium) who have paclitaxel-induced peripheral neuropathy 2.Patients scheduled to receive the same regimen as a present regimen during at least 10 weeks 3.Patients obtained informed consent in a documented form

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Adverse event Feasibility	—

Countries

Japan

Contacts

Public ContactHiroaki Nagano

Tokyo Women's Medical University, Medical Center East Obstetrics and Gynecology

naganoog@dnh.twmu.ac.jp03-3810-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026