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
  Purpose

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.


Condition Intervention Phase
Chronic Peripheral Neuropathy Pain in Diabetics
Drug: Bicifadine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by XTL Biopharmaceuticals:

Primary Outcome Measures:
  • Pain and safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bicifadine 800 mg/day for a year
Drug: Bicifadine
SR dosage form of 400 mg bid or tid for one year
Experimental: 2
Bicifadine 1200 mg/day for a year
Drug: Bicifadine
SR dosage form of 400 mg bid or tid for one year

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
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.
  • Subject participated in and completed the XTL 07-001 clinical trial.

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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.

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  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: NCT00597649

Locations
United States, Kentucky
Four Rivers Clinical Research
Paducah, Kentucky, United States
Sponsors and Collaborators
XTL Biopharmaceuticals
Investigators
Study Director: Mark Roffman, PhD XTL Biopharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Mark Roffman, Vice President, XTL Biopharmaceutical Co.
ClinicalTrials.gov Identifier: NCT00597649     History of Changes
Other Study ID Numbers: XTL B07-002, 2007-003638-40
Study First Received: January 9, 2008
Last Updated: June 29, 2009
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:
Peripheral Nervous System Diseases
Neuralgia
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014