A PHASE 2B LONG-TERM, RANDOMIZED, OPEN-LABEL, SAFETY AND TOLERABILITY TRIAL COMPARING [S,S]-REBOXETINE (PNU-165442G) WITH ROUTINE CARE IN PATIENTS WITH CHRONIC PAINFUL DIABETIC PERIPHERAL NEUROPATHY (DPN). - NA

• Conditions: Diabetic Peripheral Neuropathy; MedDRA version: 8.1Level: LLTClassification code 10012683

• Registration Number: EUCTR2006-001307-11-SE
• Lead Sponsor: Pfizer Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

· Male or female of any race at least 18 years of age.
· Female patients must be postmenopausal, or surgically sterilized, or (if they are of childbearing potential) they must be nonpregnant and nonlactating and must be using appropriate methods of contraception (including barrier or hormonal method). Women of childbearing potential must have a confirmed negative urine pregnancy test at the screening visit (V1) and at the randomization visit (V2).
· Diagnosis of type 1 or 2 diabetes mellitus (by American Diabetic Association Clinical
Practice Recommendations diagnostic criteria www.diabetes.org) for at least 1 year;
Hemoglobin A1c levels of =11% at V1 (with fluctuations of =1% in the three months
prior to this, established by comparison of V1 HbA1c result with an HbA1c result
obtained between 6-12 weeks before V1) and at V1 completion of a diabetes treatment
checklist (see Appendix A), demonstrating optimal diabetic control.· Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy, which is due to diabetes, for at least 1 year.
· Patients at V1 must have a score =40 mm on the Pain Visual Analogue Scale (VAS).
· Normal chest x-ray within 1 year prior to V1; or stable x-ray defined as no clinically significant change from previous exam (if none available, x-ray must be taken at V1).
· Patients must be able to understand and cooperate with trial procedures, and have signed a written informed consent 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 with significant hepatic impairment (i.e. AST/ALT > 2x ULN, Total bilirubin >2 x ULN).
· Clinically significant abnormal 12-lead ECG (in the opinion of the investigator).
· Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain.
· Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy.
· History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection.
· Skin conditions in the area affected by the neuropathy that (in the opinion of the investigator) could alter sensation.
· Amputations other than toes.
· Administration of any investigational drug and/or agent within 30 days prior to screening.
· Use of prohibited medications, in the absence of appropriate washout phases.
· Abuse of drugs or alcohol within the last 2 years.
· Any serious or unstable medical conditions that, in the opinion of the investigator, would compromise participation in the trial.
· Any history of, or current, significant psychiatric disorder e.g. any DSM-IV Axis I or II Disorder or patients judged clinically to be a serious suicidal risk.
· History of recurrent syncope or hypotension (systolic <90mmHg, diastolic <40mmHg).
· Postural hypotension (a fall of 20mmHg in systolic BP or 10mmHg in diastolic BP on standing).
· History of transient ischemic attack or stroke.
· Carotid bruit, unless significant carotid stenosis (e.g. >70%) has been excluded by appropriate investigation.
· History of uncontrolled narrow angle glaucoma.
· History of a seizure disorder.
· Previous exposure to reboxetine.
· History of urinary retention or prostatic hypertrophy (unless surgically corrected e.g. by TURP).
· History of heart failure (NYHA class =2) or unstable angina.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety and tolerability of [S,S]-RBX in patients with DPN.;Secondary Objective: To assess the effect of long-term treatment with [S,S]-RBX on neuropathic pain and health-related quality of life in patients with DPN.<br><br>To assess the effect of long-term treatment with [S,S]-RBX on the use of pain-related medications for the management of DPN.<br>;Primary end point(s): Safety and tolerability:<br>· Vital signs<br>· Physical examination<br>· 12-lead ECG<br>· Hematology/Biochemistry<br>· Adverse events<br>