post-herpetic neuralgia
Conditions
Interventions
Product Name: ucb 34714
Product Code: ucb 34714
Pharmaceutical Form: Capsule*
CAS Number: 357336-20-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceut
Sponsors
UCB S.A. - Pharma Sector
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent signed and dated by the subject - Male/female subject aged 18 years or older. - Pain present for at least 6 months after the healing of the acute herpes zoster skin rash. - Pain intensity score assessed on a 11-point numerical pain rating scale with a score of at least 4 at the screening visit (to assess pain intensity during the past 24 hours) and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period as evaluated on a minimum of 4 days. - Female chilbearing potential must use medically acceptable method of birth control. - Be considered as reliable and capable of adhering to the protocol. 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: - Subject getting psychological support to help cope with pain. - Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for PHN or who receives TENS. - TCAs or non-steroidal anti-inflamatory drug or permitted opioid analgesics that started less than 30 days and /or stabilized prior to screening and/or not expected to be kept at stable dose over the trial period. - Patient treated with Carbamazepine. - Subject with history of severe advers hematologic reaction to any drug - Subject with history of bone marrow depression - Any sign suggesting repidly pregressing brain disorder, dementia or brain tumor. - Known significant neurological disorder or a condition that can mimic stroke with distal neurological deficit, amyotrophy, radiculopathy, histori of transient ischemic attacks, multiple sclerosis, or any amputations. -Subject with immunidepresion - Clinically significant ECG abnormalities. - Subject with clinically significant deviations from reference range values. - Known coexistent source of pinful peripheral neuropathy. - Subjects having creatinine clearance< 50mL/min or a history of singificant impaired renal function. -Subjects treated in the four weeks prior to screening visit with strong opioids analgesics. - Subjects being treated in the two weeks prior to screening visit with: skeletal muscle-relaxants, AEDs, mexiletine, anesthetics, topical analgesics, antiviral agents - Subjects treated in the week prior to the screening visit with: any other treatment considered efficacious in the treatment of post-herpetic neuralgia- Aspirin <300 mg/day may be taken for the prophylaxis of myocardial infarction or transient ischemic attacks. -Subject treated with over-the-counter and/or homeopathy analgesics. - Subject having a past history or is currently abusing alcohol or any other drug according to the DSM-IV criteria. -Pregnant, lactating or sexually active woman with childbearing potential who is not using a medically accepted birth control method or who is using an OC containing<30ug ethinylestradiol, in case she is taking hormonal contraception. - Known psychiatric condition (inluding suicidal ideation in past three months or history of attempted suicide in the past ten years). -Contraindication to any component of the treatments in the trial (ucb 34714 or placebo) or known allergic reaction to or intolerance of pyrrolidine derivates and /or other excipients (principally lactose, cornstarch, cellulose). - Subject currently participating or having participated within the last 30 days in another clinical trial. - Investigators, co-investigators, theri spouses or children or any trial collaborator may not be included as subjects in the trial. - Subject having been blood donator during the previous 3 months or planning to be blood donator during the trial. -Presence of any sign suggestign rapidly progressing brain disorder, dementia or brain tumor. - Any significant clinical and/or medical contidions (acute or chronic illness such as but not restricted to: severe cardiac dysfunction, bone marrow depression, severe hepatic disease and /or moderate to severe rena impairment) with may contraindicate the use of ucb 34714, impair reliable participation in the trial or necessitate the use of medication not allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy of each dose of ucb 34714 (200 mg/day and 400 mg/day) copared with placebo, in the treatment of post-herpetic neuralgia;Secondary Objective: Secondary objective: To explore the safety and tolerability of ucb 34714 in the same indication Exploratory objective: To explore the impact on subject´s self-reported health status To collect data on painfree days and on medical resources used during the study;Primary end point(s): - to evaluate the efficacy of each dose of ucb 34714 (200mg/day and 400mg/day) compared with placebo, in the treatment of Post-herpetic Neuralgia. | — |
Countries
Czech Republic, Slovakia, Spain
Outcome results
None listed