[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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005555-17-LV
• Date of registration: 13/02/2008
• Prospective Registration: No
• Primary sponsor: Pfizer Ltd
• 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. - NA
• 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. - NA
• Date of first enrolment: 21/07/2006
• Target sample size: 361
• 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: 8.1 Level: LLT Classification code 10029223

Intervention(s)

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 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
Concentra

Primary Outcome(s)

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.

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

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

Secondary ID(s)

A6061021

2005-005555-17-SE