Phase II study of KHK6188

Phase 2

• Conditions: Postherpetic neuralgia

• Registration Number: JPRN-jRCT2080221716
• Lead Sponsor: Kyowa Hakko Kirin Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Patients with pain for 3 months or more and 1 year or less following onset of a herpes zoster rash
- Patients with a mean pain intensity score (11-point numerical rating scale) of 4 or more
- Patients whose rash has been healed
- Patients who are able to fill their patient diary
- Patients who provided written voluntary informed consent to participate in the study

Exclusion Criteria

- Patiens who have other pain or disease which may impair the self assessment of pain
- Patients who have dementia, depression or schizophrenia which may affect the self assessment of pain
- History or presence of severe cardiovascular disease, hepatic dysfunction, renal failure, respiratory disease, blood disease or CNS disorder
- History or presence of a drug allergy
- Patients who have a history of a diagnosis of cancer or a treatment of cancer within 5 years prior to the study entry
- Patients received an investigational medication within 4 months (6 months for biologic medication such as antibody) prior to the informed consent
- Women of child bearing potential who do not agree to avoid pregnancy from the time of providing the consent until 3 months after the end of dosing, or men of reproductive potential who do not agree to avoid pregnancy from the time of the first dose until 3 months after the end of dosing
- Patients who are pregnant, lactating, or possibly pregnant
- Patients judged to be inappropriate to enter the study by a investigator or a subinvestigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy, Safety<br><br>Efficacy: Change of pain intensity score <br>Safety: adverse events

Secondary Outcome Measures

Name	Time	Method
Allodynia, Global impression<br>Change of allodynia severity, change of global impression