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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. |
Register:
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EUCTR |
Last refreshed on:
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27 July 2020 |
Main ID: |
EUCTR2005-005555-17-GB |
Date of registration:
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11/04/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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[S,S]-REBOXETINE ADD-ON TRIAL: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL OF [S,S]-REBOXETINE IN PATIENTS WITH POSTHERPETIC NEURALGIA (PHN) CONCOMITANTLY TREATED WITH PREGABALIN. - NA
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Scientific title:
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[S,S]-REBOXETINE ADD-ON TRIAL: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL OF [S,S]-REBOXETINE IN PATIENTS WITH POSTHERPETIC NEURALGIA (PHN) CONCOMITANTLY TREATED WITH PREGABALIN. - NA |
Date of first enrolment:
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27/06/2006 |
Target sample size:
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361 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005555-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes 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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Austria
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Czech Republic
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Germany
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Italy
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Latvia
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Netherlands
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Spain
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: · Male or female, at least 18 years of age · Female patients must be non-pregnant and non-lactating, and be either postmenopausal, surgically sterilized, or using an appropriate method of contraception (including barrier or hormonal method). Women of childbearing potential must have a confirmed negative urine pregnancy test at the Screening visit (Visit 1) · Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash. There is no upper limit on the duration of PHN · Patients at screening visit (Visit 1) must have a score =40 mm on the Pain Visual Analogue Scale (VAS) · Patients must be able to understand and cooperate with trial procedures and have signed a written informed consent document prior to entering the trial
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: · Malignancy within the past 2 years with the exception of basal cell carcinoma · Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for PHN · Creatinine clearance <30 Ml/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation) · Patients with significant hepatic impairment (i.e. AST/ALT >2 x ULN, Total bilirubin >2 x ULN) · Platelet count <100 x 10E3/mm3; white blood cell (WBC) count <2.5 x 10E3/ mm3; neutrophil count <1.5 x 10E3/ mm3 · History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection · Patients having other severe pain, which may impair the self-assessment of the pain due to PHN · Patients who have a history of alcohol or drug abuse in the past 2 years · Clinically significant abnormal 12-lead ECG · Skin conditions in the affected dermatome that could alter sensation, other than PHN · Use of prohibited medications in the absence of appropriate washout periods · History or current episode of major depressive disorder as defined by DSM-IV diagnostic criteria · Depression sub-scale score >10 on the Hospital and Anxiety Depression Scale · History of recurrent syncope or evidence of low blood pressure (<90 mmHg systolic or <40 mmHg diastolic) · Evidence of symptomatic postural hypotension. This includes relevant postural symptoms associated with fall in systolic blood pressure of >20 mmHg or diastolic blood pressure >10 mmHg on standing (from sitting) · Patients with a history of transient ischemic attacks, stroke, or the presence of a carotid bruit (unless significant carotid stenosis (>70%) has been ruled out by appropriate investigation) · History of uncontrolled narrow angle glaucoma · Patients judged clinically to be a serious suicidal risk · Patients who have a history of a seizure disorder · Previous exposure to either pregabalin or RBX · Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to Visit 1 · Have ever received treatment with vigabatrin, hydroxychloroquine, deferoxamine, thioridazine and or any compound known to adversely affect retina and visual fields · Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the trial
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Postherpetic Neuralgia` MedDRA version: 8.1
Level: LLT
Classification code 10029223
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Intervention(s)
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Product Name: [S,S]-Reboxetine Succinate Product Code: PNU-165442G Pharmaceutical Form: Tablet INN or Proposed INN: (+)-[S,S]-Reboxetine succinate Current Sponsor code: PNU-165442G Other descriptive name: [S,S]-RBX, (2S)-2-[(S)-(2-ethoxyphenoxy) phenylmethyl]morpholine succinate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: [S,S]-Reboxetine Succinate Product Code: PNU-165442G Pharmaceutical Form: Tablet INN or Proposed INN: (+)-[S,S]-Reboxetine succinate Current Sponsor code: PNU-165442G Other descriptive name: [S,S]-RBX, (2S)-2-[(S)-(2-ethoxyphenoxy) phenylmethyl]morpholine succinate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: [S,S]-Reboxetine Succinate Product Code: PNU-165442G Pharmaceutical Form: Tablet INN or Proposed INN: (+)-[S,S]-Reboxetine succinate Current Sponsor code: PNU-165442G Other descriptive name: [S,S]-RBX, (2S)-2-[(S)-(2-ethoxyphenoxy) phenylmethyl]morpholine succinate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: Lyrica Product Code: Pregabalin Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pregabalin CAS Number: 148553-50-8 Current Sponsor code: PD 0144723 (CI-1008) Other descriptive name: (S)-(+)-3-isobutyl-GABA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
Product Name: Lyrica Product Code: Pregabalin Pharmaceutical Form: Capsule, hard INN or Proposed IN
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Primary Outcome(s)
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Primary end point(s): Change from baseline to Week 10 in weekly average pain score. Pain intensity is based on the daily pain rating scale of 0-10.
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Secondary Objective: To investigate the safety and tolerability of [S,S]-RBX in adjunctive treatment with pregabalin in patients with PHN
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Main Objective: To compare the efficacy of adjunctive treatment of pregabalin with [S,S]-RBX against pregabalin monotherapy in patients with PHN
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Secondary ID(s)
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A6061021
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2005-005555-17-SE
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 17/10/2006
Contact:
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