Back to resultsA 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Primary Purpose
Chronic Peripheral Neuropathy Pain in Diabetics
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bicifadine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Peripheral Neuropathy Pain in Diabetics
Eligibility Criteria
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.
Contact site for additional information.
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.
Contact site for additional information.
Sites / Locations
- Four Rivers Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Bicifadine 800 mg/day for a year
Bicifadine 1200 mg/day for a year
Outcomes
Primary Outcome Measures
Pain and safety
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00597649
Brief Title
A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
The 001 trial did not show benefit versus placebo
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
XTL Biopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Peripheral Neuropathy Pain in Diabetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Bicifadine 800 mg/day for a year
Arm Title
2
Arm Type
Experimental
Arm Description
Bicifadine 1200 mg/day for a year
Intervention Type
Drug
Intervention Name(s)
Bicifadine
Intervention Description
SR dosage form of 400 mg bid or tid for one year
Primary Outcome Measure Information:
Title
Pain and safety
Time Frame
one year
Secondary Outcome Measure Information:
Title
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
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Contact site for additional information.
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.
Contact site for additional information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Roffman, PhD
Organizational Affiliation
XTL Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.xtlbio.com
Description
Sponsor's website
Learn more about this trial
A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
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