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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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2 August 2021 |
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Main ID: |
EUCTR2004-000975-32-ES |
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Date of registration:
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16/09/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An exploratory, double blind, randomized, placebo-controlled, prallel group, multicenter study, for the assessment of the efficacy, safety and tolerability of ucb34714 50mg oral capsules in b.i.d. administration at the dose of 200mg/day and 400mg/day, in subjects (at least 18 years old) suffering from post-herpetic neuralgia (PHN). - N01162
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Scientific title:
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An exploratory, double blind, randomized, placebo-controlled, prallel group, multicenter study, for the assessment of the efficacy, safety and tolerability of ucb34714 50mg oral capsules in b.i.d. administration at the dose of 200mg/day and 400mg/day, in subjects (at least 18 years old) suffering from post-herpetic neuralgia (PHN). - N01162 |
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Date of first enrolment:
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09/11/2004 |
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Target sample size:
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150 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000975-32 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Slovakia
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Spain
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Key inclusion & exclusion criteria
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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:
- 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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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post-herpetic neuralgia
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Intervention(s)
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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-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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
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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
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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.
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Secondary ID(s)
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RPCE03L1801
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 19/10/2004
Contact:
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