Back to resultsDouble Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bicifadine
Bicifadine
Bicifadine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy
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
- 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
Sites / Locations
- Four Rivers Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Drug
Drug: 2
Control
Arm Description
Bicifadine
Bicifadine
Placebo of Bicifadine
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
NCT ID
NCT00553592
First Posted
November 1, 2007
Last Updated
November 2, 2007
Sponsor
XTL Biopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00553592
Brief Title
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
XTL Biopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
336 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug
Arm Type
Experimental
Arm Description
Bicifadine
Arm Title
Drug: 2
Arm Type
Experimental
Arm Description
Bicifadine
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo of Bicifadine
Intervention Type
Drug
Intervention Name(s)
Bicifadine
Intervention Description
600mg/day
Intervention Type
Drug
Intervention Name(s)
Bicifadine
Intervention Description
placebo tablet
Intervention Type
Drug
Intervention Name(s)
Bicifadine
Intervention Description
1200 mg
Primary Outcome Measure Information:
Title
Pain and Safety
Time Frame
14 weeks
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
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivy Raso
Phone
845-267-0707
Ext
222
Email
iraso@xtlbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Barnes, MT
Phone
512-306-4254
Email
kbarnes@incresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Roffman, PhD
Organizational Affiliation
XTL Bio
Official's Role
Study Director
Facility Information:
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse Wallace, MD
Phone
270-441-4606
Email
diargent@fourriversresearch.com
First Name & Middle Initial & Last Name & Degree
Caron Massey
Phone
270-441-4606
Email
cmassey@fourriversresearch.com
First Name & Middle Initial & Last Name & Degree
Jesse Wallace, MD
12. IPD Sharing Statement
Links:
URL
http://www.xtlbio.com
Description
Sponsor's website
Learn more about this trial
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
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