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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by XTL Biopharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
XTL Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00553592
First received: November 1, 2007
Last updated: November 2, 2007
Last verified: November 2007

November 1, 2007
November 2, 2007
September 2007
Not Provided
Pain and Safety [ Time Frame: 14 weeks ]
Same as current
Complete list of historical versions of study NCT00553592 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: 14 weeks ]
Same as current
Not Provided
Not Provided
 
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Peripheral Neuropathy
  • Drug: Bicifadine
    600mg/day
  • Drug: Bicifadine
    placebo tablet
  • Drug: Bicifadine
    1200 mg
  • Experimental: Drug
    Bicifadine
    Intervention: Drug: Bicifadine
  • Experimental: Drug: 2
    Bicifadine
    Intervention: Drug: Bicifadine
  • Placebo Comparator: Control
    Placebo of Bicifadine
    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.
 
Recruiting
336
December 2008
Not Provided

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
Both
18 Years and older
No
Contact: Ivy Raso 845-267-0707 ext 222 iraso@xtlbio.com
Contact: Kevin Barnes, MT 512-306-4254 kbarnes@incresearch.com
United States
 
NCT00553592
XTL B07-001
No
Not Provided
XTL Biopharmaceuticals
Not Provided
Study Director: Mark Roffman, PhD XTL Bio
XTL Biopharmaceuticals
November 2007

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