NCT00597649

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

Enrollment Period

1.2 years

First QC Date

January 9, 2008

Last Update Submit

June 29, 2009

Conditions

Chronic Peripheral Neuropathy Pain in Diabetics

Outcome Measures

Primary Outcomes (1)

  • Pain and safety

    one year

Secondary Outcomes (1)

  • 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

    One year

Study Arms (2)

1

EXPERIMENTAL

Bicifadine 800 mg/day for a year

Drug: Bicifadine

2

EXPERIMENTAL

Bicifadine 1200 mg/day for a year

Drug: Bicifadine

Interventions

BicifadineDRUG

SR dosage form of 400 mg bid or tid for one year

12

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Four Rivers Clinical Research

Paducah, Kentucky, United States

Location

Related Links

MeSH Terms

Interventions

bicifadine

Study Officials

  • Mark Roffman, PhD

    XTL Biopharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

US(1)