Phase III study of FTB-8127 in patients with post-herpetic neuralgia (A placebo-controlled, multicenter, double-blind, parallel-group study)

Phase 3

Completed

• Conditions: Post-herpetic neuralgia

• Registration Number: JPRN-jRCT2080220444
• Lead Sponsor: FUSO Pharmaceutical Industries, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-19
• Study Completion: 2009-05-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

(1) Patients who have been over 3 months after the onset of herpes zoster
(2) Patients aged 20 years or older at the time of informed consent
(3) Patients providing written informed consent about participation in this clinical trial
(4) Hospitalized patients and outpatients. In outpatients, who may be able to visit once a week
(5) Patients who have been treated with drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics adjuvants for PHN within 2 weeks before the start of the pre-observation period
(6) In case of undergoing nerve block therapy, patients who are treated regularly (once a week or once every 2 weeks) or may be able to be treated regularly for 2 weeks before the start of the pre-observation period
(7) Out of 7 days of the pre-observation period (measured three times a day in the morning, daytime, and night), patients getting a maximum daily VAS pain score of 40 or more and having been gotten a maximum daily pain degree (Verbal Rating Scale: VRS) of moderate to severe for 4 days or more respectively

Exclusion Criteria

(1) Patients with head disorders or brain lesions who are suspected of obnubilation
(2) Patients with a history or complication of elevated intracranial pressure
(3) Patients with consciousness disorders (e.g., unable to speak) or convulsions (e.g., status epilepticus)
(4) Patients with serious respiratory depression and pulmonary function impairment
(5) Patients with a history or complication of malignancies
(6) Patients with a history of hypersensitivity to opioid analgesics
(7) Patients who used opioid analgesics within 4 weeks before the start of the pre-observation period
(8) Patients who are drug addicts or drug abusers or who have a history of drug dependence
(9) Patients who are pregnant, lactating, or who have the possibility of pregnancy, or who wish to become pregnant during the clinical trial period
(10) Patients who participated in another clinical trial within 90 days before the start of the pre-observation period
(11) Patients with AST (GOT), ALT (GPT) of 100IU/L or more, total bilirubin of 3.0mg/dL or more, and serum creatinine of 2.0mg/dL or more on laboratory data up to 4 weeks before the start of the pre-observation period
(12) Patients who started the following pain relief treatments during the pre-observation period
1) Opioid analgesics, non-opioid analgesics, analgesics adjuvants, nerve block
2) Surgery that may affect pain assessment
3) Prohibited drugs (barbiturate derivatives, MAO inhibitors, CYP3A4 inhibitors)
(13) Patients who are judged to be inadequate by the investigator, etc

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>confirmatory<br>-

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>-