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
  Purpose

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.


Condition Intervention Phase
Diabetic Peripheral Neuropathy
Drug: Bicifadine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by XTL Biopharmaceuticals:

Primary Outcome Measures:
  • Pain and Safety [ Time Frame: 14 weeks ]

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 [ Time Frame: 14 weeks ]

Estimated Enrollment: 336
Study Start Date: September 2007
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
Experimental: Drug
Bicifadine
Drug: Bicifadine
600mg/day
Experimental: Drug: 2
Bicifadine
Drug: Bicifadine
1200 mg
Placebo Comparator: Control
Placebo of Bicifadine
Drug: Bicifadine
placebo tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553592

Contacts
Contact: Ivy Raso 845-267-0707 ext 222 iraso@xtlbio.com
Contact: Kevin Barnes, MT 512-306-4254 kbarnes@incresearch.com

Locations
United States, Kentucky
Four Rivers Clinical Research Recruiting
Paducah, Kentucky, United States, 42003
Contact: Jesse Wallace, MD    270-441-4606    diargent@fourriversresearch.com   
Contact: Caron Massey    270-441-4606    cmassey@fourriversresearch.com   
Principal Investigator: Jesse Wallace, MD         
Sponsors and Collaborators
XTL Biopharmaceuticals
Investigators
Study Director: Mark Roffman, PhD XTL Bio
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00553592     History of Changes
Other Study ID Numbers: XTL B07-001
Study First Received: November 1, 2007
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India

Additional relevant MeSH terms:
Neuralgia
Peripheral Nervous System Diseases
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014