Patients suffering from pain due to post-herpetic neuralgia
Conditions
Interventions
Product Name: 2PX
Pharmaceutical Form: Cutaneous solution
Pharmaceutical form of the placebo: Cutaneous solution
Route of administration of the placebo: Topical use (Noncurrent)
Sponsors
Santosolve A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are: At Visit 1: 1. Male or female out-patients, 18 years or older. 2. Subjects who have given their written informed consent. 3. Subjects who have had post-herpetic neuralgia for at least three months after healing of a herpes zoster skin rash. 4. Moderate or severe pain (pain intensity score of =4 (on an 11-point NRS) as the average daily score as recalled over each of the last seven days). 5. At baseline, female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test. At Visit 2: 1. Prior to randomisation, subjects must report an improvement in their average daily (diary) pain intensity by two or more points on the 11-point NRS compared to Visit 1 based upon at least four out of seven days during Week 2. 2. Prior to randomisation subjects must report an improvement in their recalled clinic pain intensity by two points or more on the 11 point NRS compared to Visit 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from entry into the study: 1. Subjects with active herpes zoster lesions or dermatitis of any origin at the affected site of PHN. 2. Subjects with evidence for another cause of pain in the area affected by herpes zoster (in addition to PHN), such as surgery, trauma or lumbar radiculopathy, if this could confound assessment or self-evaluation of pain due to PHN. 3. Subjects with any bodily moderate to severe pain, e.g. osteoarthritis, that could confound assessment or self-evaluation of pain due to PHN. 4. Subjects using topically applied medication on the area affected by PHN or those taking opioids (including tramadol). Stable doses of gabapentin, tricyclic antidepressants and pregabalin are allowed, provided that the dose has been stable for one month prior to Visit 1. 5. Subjects who have had neuro-ablation or neurosurgical intervention for their PHN. 6. Subjects who are undergoing active treatment for cancer, are known to be infected by HIV, or being acutely and intensively immunosuppressed following transplantation. 7. Subjects with documented or suspected alcohol or drug abuse. 8. Subjects known to have a condition that, in the investigator’s judgement, precludes participation in the study. 9. Subjects with a significant psychiatric disorder, in the opinion of the investigator, or subjects receiving strong anti-psychotic medication. 10. Female subjects who are pregnant or breast-feeding. 11. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry. 12. Subjects unable to comply with the study assessments or complete the questionnaires. 13. Subjects who have previously been admitted to this study. 14. Subjects who are shown to have abnormal haematology and biochemistry results from investigations taken at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of 2PX versus placebo in patients with neuropathic pain due to post-herpetic neuralgia.;Secondary Objective: The secondary objective is to evaluate the tolerability, and local and systemic effects of 2PX.;Primary end point(s): The primary efficacy variable is the “time to exit” during the double-blind phase. Subjects will exit the double-blind phase if their daily diary pain intensity score deteriorates by two or more points on the 11-point NRS scale on two consecutive days in comparison to the pain intensity at Visit 2. | — |
Countries
United Kingdom
Outcome results
None listed