NCT00553592

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
336

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 5, 2007

Status Verified

November 1, 2007

First QC Date

November 1, 2007

Last Update Submit

November 2, 2007

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Pain and Safety

    14 weeks

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

    14 weeks

Study Arms (3)

Drug

EXPERIMENTAL

Bicifadine

Drug: Bicifadine

Drug: 2

EXPERIMENTAL

Bicifadine

Drug: Bicifadine

Control

PLACEBO COMPARATOR

Placebo of Bicifadine

Drug: Bicifadine

Interventions

BicifadineDRUG

600mg/day

Drug

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Four Rivers Clinical Research

Paducah, Kentucky, 42003, United States

RECRUITING

Related Links

MeSH Terms

Interventions

bicifadine

Study Officials

  • Mark Roffman, PhD

    XTL Bio

    STUDY DIRECTOR

Central Study Contacts

Ivy Raso

CONTACT

845-267-0707iraso@xtlbio.com

Kevin Barnes, MT

CONTACT

512-306-4254kbarnes@incresearch.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 2007

First Posted

November 5, 2007

Study Start

September 1, 2007

Study Completion

December 1, 2008

Last Updated

November 5, 2007

Record last verified: 2007-11

Locations

US(1)