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

Inclusion Criteria10

Patients will be entered into this study only if they meet all of the following criteria;
be able to give voluntary written informed consent to participate in the study;
be over eighteen years of age;
be diagnosed as suffering from post herpetic neuralgia defined as pain persisting for more than six months after onset of herpes zoster rash;
be diagnosed as suffering from moderate to severe pain across the Screening Period;
willing and be able to comply with all study procedures;
for females, have a negative pregnancy test at the Screening Visit (Visit 1) and at Visit 2 (Day 1) prior to administration of study medication;
for females, be of non-child-bearing potential (i.e. either surgically sterilised or one year post-menopausal), or if of child-bearing potential, must have used adequate contraceptive precautions for 30 days prior to screening, and must agree to use two approved methods of contraception for the duration of the study, and for one month after administration of the last dose of study medication;
for males, agree to use two approved methods of contraception for the duration of the study and until 1 month after administration of the last dose of the study medication, where approved methods of contraception include surgical sterilization (vasectomy at least 6 months prior to dosing), condom use by male partners of female patients or by male patients, birth control pills, diaphragm with vaginal spermicide, intra uterine device, contraceptive hormonal patches, implants or injections by female patients or female partners of male patients;
and be fluent in the language of the endpoint scales provided to patients in the study.

Exclusion Criteria19

Patients who meet any of the following criteria will be excluded from participating in the study;
be currently receiving any of the listed prohibited medications or have received within 30 days prior to the Screening Visit (Visit 1) or is anticipated to receive after the start of the trial (i.e. on or after Visit 1) any new prescription systemic or topical medication for their post herpetic neuralgia, patients may be enrolled if stable on therapy for their post herpetic neuralgia as specified in the list of permitted medications;
have received an investigational drug within 30 days or 10 half-lives of the drug, whichever is longer, prior to the Screening Visit (Visit 1) or have previously received EMA401; known to be allergic to EMA401 or any of the excipients or who have a history of an allergic reaction to previous medication that required management by a health care professional;
have a clinically significant history of systemic allergic disease (e.g., urticaria, atopic dermatitis);
have a blood pressure, after resting for at least 5 minutes, outside a systolic blood pressure range of 100-150 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements (at least 10 minutes apart and completed within 20 minutes of the initial measurement);
have a pulse rate, after sitting for at least 5 minutes, greater than 100 beats per minute or lower than 50 beats per minute, or 45 beats per minute if on beta blockers, on two consecutive measurements (at least 10 minutes apart and completed within 20 minutes of the initial measurement);
known to be diabetic;
consume more than 4 units of alcohol daily for a man or 3 units of alcohol for a woman (1 unit equals 300 mL beer, one glass of wine, one measure of spirits) or has a history of alcohol abuse/dependence;
have evidence of significant renal insufficiency, indicated by an estimated creatinine clearance using the Cockcroft-Gault formula of less than 50 mL/min at Screening (Visit 1);
have serum aspartate transaminase, gamma glutamyl transaminase or alanine transaminase levels greater than 3 times the upper limit of normal or have total bilirubin concentrations greater than 2 times the upper limit of normal at Screening (Visit 1);
other than pain as a result of postherpetic neuralgia, have an active, uncontrolled medical condition (e.g., neurological, gastrointestinal, renal, hepatic, cardiovascular, pulmonary, metabolic, endocrine, haematological, genitourinary or other major disorder), or psychiatric illness (e.g., depression, schizophrenia), or any other significant clinical disorder or laboratory finding that in the opinion of the investigator, precludes participation in the study or may interfere with the study objectives;
other than pain as a result of postherpetic neuralgia, have had a clinically significant illness or operative procedure within 4 weeks of the Screening Visit (Visit 1) (e.g. influenza, myocardial infarction);
have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia;
have other moderate to severe pain condition that may confound the self-evaluation of pain due to postherpetic neuralgia;
have skin conditions in the affected area that in the investigator's opinion could alter sensation;
have active herpes zoster upon physical examination at Screening (Visit 1) or during the study;
have hepatitis B, hepatitis C or human immunodeficiency virus infection as defined by being seropositive for hepatitis B surface antigen, hepatitis C virus antibodies or human immunodeficiency virus antibodies respectively;
have a history of at least one genital herpes outbreak;
or are pregnant or lactating.

Interested in this trial?

Get notified about updates and connect with the research team.

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.