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. - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005555-17-IT
• Date of registration: 23/06/2006
• Prospective Registration: Yes
• Primary sponsor: PFIZER
• Public title: 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. - ND
• Scientific title: 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. - ND
• Date of first enrolment: 02/08/2006
• Target sample size: 391
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005555-17
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Czech Republic, Germany, Italy, Latvia, Netherlands, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Postherpetic Neuralgia
MedDRA version: 6.1 Level: PT Classification code 10036376

Intervention(s)

Product Name: S,S, Reboxetina
Product Code: PNU-165442G
Pharmaceutical Form: Tablet
Current Sponsor code: PNU-165442G
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, Reboxetina
Product Code: PNU-165442G
Pharmaceutical Form: Tablet
Current Sponsor code: PNU-165442G
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, Reboxetina
Product Code: PNU-165442G
Pharmaceutical Form: Tablet
Current Sponsor code: PNU-165442G
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
CAS Number: 148553-50-8
Current Sponsor code: PD 0144723 CI-1008
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Name: Lyrica
Product Code: Pregabalin
Pharmaceutical Form: Capsule, hard
CAS Number: 148553-50-8
Current Sponsor code: PD 0144723 CI-1008
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Product Name: Lyrica
Product Code: Pregabalin
Pharmaceutical Form: Capsule, hard
CAS Number: 148553-50-8
Current Sponsor code: PD 0144723 CI-1008
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Product Name: Lyrica
Product Code: Pregabalin
Pharmaceutical Form: Capsule, hard
CAS Number: 148553-50-8
Current Sponsor code: PD 0144723 CI-1008
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: Lyrica
Product Code: Pregabalin
Pharmaceutical Form: Capsule, hard
CAS Number: 148553-50-8
Current Sponsor code: PD 0144723 CI-1008
Concent

Primary Outcome(s)

Main Objective: To compare the efficacy of adjunctive treatment of pregabalin with S,S -RBX against pregabalin monotherapy in patients with PHN

Primary end point(s): Change from baseline to week 10 in weekly average pain score. Pain intensity is based on the daily pain diary numerical rating scale of 0-10

Secondary Objective: To investigate the safety and tolerability of S,S -RBX in adjunctive treatment with pregabalin in patients with PHN

Secondary ID(s)

2005-005555-17-SE

A6061021