Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00553592
• Other study ID #: XTL B07-001
• Status: Recruiting
• Phase: Phase 2
• First received: November 1, 2007
• Last updated: November 2, 2007
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2007
• Source: XTL Biopharmaceuticals
• Contact: Ivy Raso
• Phone: 845-267-0707
• Email: iraso[@]xtlbio.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients.

To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, 18 years or older

• Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus

• Chronic bilateral pain due to diabetic neuropathy

• Pain for at least six months

• Primary pain is located in the feet

• Others-contact site for information

Exclusion Criteria:

• Symptoms of other painful conditions

• Presence of amputations other than toes

• Clinically significant psychiatric or other neurological disorder

• Use of certain medications

• Clinically important other diseases

• Pregnancy

• History of alcohol or narcotic abuse within two years

• Others-contact site for information

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Drug:
• Bicifadine
600mg/day
• Bicifadine
placebo tablet
• Bicifadine
1200 mg

Locations

Country	Name	City	State
United States	Four Rivers Clinical Research	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
XTL Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and Safety		14 weeks
Secondary	Clinical Global Impression of Improvement, McGill Pain Questionnaire, Amount of Rescue Medication Used for Pain, Quality of Life Survey (SF-36), Patient Global Impression of Change		14 weeks