Recruiting
Phase 2

Bicifadine SR

Sponsor:

XTL Biopharmaceuticals

Code:

NCT00553592

Conditions

Diabetic Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bicifadine

Bicifadine

Bicifadine

Study Details

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.

Conditions

Diabetic Peripheral Neuropathy

Study ID

NCT00553592

Start date

Sep, 2007

Status verified date

Nov, 2007

Completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

336 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Drug

Bicifadine

experimental: Drug: 2

Bicifadine

placebo comparator: Control

Placebo of Bicifadine

Interventions

Bicifadine

600mg/day

Bicifadine

placebo tablet

Bicifadine

1200 mg

Primary outcome measure

  • Pain and Safety [ Time Frame: 14 weeks ]

Central Contacts and Locations

Central contacts

Ivy Raso

845-267-0707iraso@xtlbio.com

Kevin Barnes, MT

512-306-4254kbarnes@incresearch.com

Locations

Four Rivers Clinical Research

Recruiting

Paducah, Kentucky, United States, 42003

Contacts

Jesse Wallace, MD

270-441-4606diargent@fourriversresearch.com

Caron Massey

270-441-4606cmassey@fourriversresearch.com

Principal Investigator:

Jesse Wallace, MD

More Information

Sponsor

XTL Biopharmaceuticals

Last update posted

Nov 4, 2007

Last verified

Nov, 2007

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by XTL Biopharmaceuticals on 2007-11-04.