A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Chronic Peripheral Neuropathy Pain in Diabetics Clinical Trial

Official title:

An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00597649
• Other study ID #: XTL B07-002
• Secondary ID: 2007-003638-40
• Status: Terminated
• Phase: Phase 2
• First received: January 9, 2008
• Last updated: June 29, 2009
• Start date: October 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: XTL Biopharmaceuticals
• Contact: n/a
• 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

This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

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.

• Subject participated in and completed the XTL 07-001 clinical trial.

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Exclusion Criteria:

• Symptoms of other painful conditions

• Presence of amputations other than toes

• Clinically significant psychiatric or other neuropsychological disorder

• Use of certain medications

• Clinically important other diseases

• Pregnancy

• History of alcohol or narcotic abuse within two years.

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Peripheral Neuropathy Pain in Diabetics
• Diabetic Neuropathies
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Drug:
• Bicifadine
SR dosage form of 400 mg bid or tid for one year

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		one year	Yes
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		One year	Yes