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

This study has been terminated.
(The 001 trial did not show benefit versus placebo)
Sponsor:
Information provided by:
XTL Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00597649
First received: January 9, 2008
Last updated: June 29, 2009
Last verified: June 2009

January 9, 2008
June 29, 2009
October 2007
December 2008   (final data collection date for primary outcome measure)
Pain and safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00597649 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Peripheral Neuropathy Pain in Diabetics
Drug: Bicifadine
SR dosage form of 400 mg bid or tid for one year
  • Experimental: 1
    Bicifadine 800 mg/day for a year
    Intervention: Drug: Bicifadine
  • Experimental: 2
    Bicifadine 1200 mg/day for a year
    Intervention: Drug: Bicifadine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
250
December 2008
December 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00597649
XTL B07-002, 2007-003638-40
No
Mark Roffman, Vice President, XTL Biopharmaceutical Co.
XTL Biopharmaceuticals
Not Provided
Study Director: Mark Roffman, PhD XTL Biopharmaceuticals
XTL Biopharmaceuticals
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP