CompletedPhase 2ACTRN12611000822987

A study of oral EMA401 in the treatment of pain following shingles to see if EMA401 can reduce the level of pain.

A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the safety, tolerability and pharmacokinetic profile of EMA401 (angiotensin II type 2 receptor antagonist) administered orally in patients with postherpetic neuralgia.

Sponsor

Spinifex Pharmaceuticals Pty Ltd

Enrollment

172 participants

Start Date

Aug 10, 2011

Study Type

Interventional

Conditions

Postherpetic Neuralgia

Summary

This is a proof of concept study designed to investigate the efficacy of EMA401 when administered orally, twice daily (200 mg total daily dose) for 28 days in patients with postherpetic neuralgia aged 18 years old and over. The secondary objectives of the study are to determine the safety, tolerability and pharmacokinetic profile of EMA401 and to evaluate the efficacy of EMA401 using a number of alternate endpoints.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests EMA401, an oral medication, for reducing pain caused by post-herpetic neuralgia (lingering pain after shingles). Adults aged 18 and older who have had pain persisting for more than 6 months after a shingles rash and who have moderate to severe pain levels are eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

EMA401 sodium salt capsules (2 x 50 mg) will be administered at a dose of 100 mg twice daily, taken on an empty stomach at least 1 hour before a meal (total 200 mg daily dose). The two capsules o

EMA401 sodium salt capsules (2 x 50 mg) will be administered at a dose of 100 mg twice daily, taken on an empty stomach at least 1 hour before a meal (total 200 mg daily dose). The two capsules on each dosing occasion should be taken orally with a minimum of 200 mL of water. The Treatment Period will be 29 days consisting of 28 days of twice daily dosing and a single dose on the morning of Day 29, to give a total of 57 doses, followed by 13 days (+/- 3 days) without treatment.