Neuropathic PainPhase 2NCT00683423
BMS-741672 for Diabetic Neuropathic Pain
A Phase 2 study testing BMS-741672 in people with Neuropathic Pain, run by Bristol-Myers Squibb at 8 sites in United States.
Trial summary
The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- BMS-741672
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2008to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or 2 diabetics with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration
- Screening HbA1c of ≥ 7% and ≤ 10%
- BMI ≤ 40 kg/m2
Who cannot join
- Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, central nervous system (CNS), psychiatric, endocrine (other than diabetes), tuberculosis or renal
- Women of childbearing potential
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
The Pain & Rehabilitation Clinic Of Chicago
Chicago, Illinois, 60610
Research Institute Of Dallas, P.A.
Dallas, Texas, 75231
Physicians East P.A.
Greenville, North Carolina, 27834
Advanced Biomedical Research Of America
Las Vegas, Nevada, 89123
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33418
Comprehensive Neurosciences, Inc.
St. Petersburg, Florida, 33702
Neurology Center Of Ohio
Toledo, Ohio, 43623
University Clinical Investigators, Inc.
Tustin, California, 92780
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Efficacy and Safety of BMS-741672 in Patients With Diabetic Neuropathic Pain
The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.
- Conditions
- Neuropathic Pain
- Being tested
- BMS-741672, Placebo
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-741672Drug
Tablets, Oral, 100 mg, once daily, 3 weeks
PlaceboDrug
Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: BMS-741672 |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores
Measured: recorded during the last 7 days of treatment in each period
Secondary outcomes (1)
Other glycemic, vascular, and mechanism-based biomarkers will be measured
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683423
- Sponsor's protocol ID
- MB114-006
- Status last verified
- Sep 2015
- First submitted
- 21 May 2008
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Efficacy and Safety of BMS-741672 in Patients With Diabetic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00683423
- Acronym / sponsor ID
- MB114-006
- Conditions
- Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: BMS-741672 |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 or 2 diabetics with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration
- Screening HbA1c of ≥ 7% and ≤ 10%
- BMI ≤ 40 kg/m2
Key exclusion criteria (2 listed)
- Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, central nervous system (CNS), psychiatric, endocrine (other than diabetes), tuberculosis or renal
- Women of childbearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-741672Tablets, Oral, 100 mg, once daily, 3 weeks | Drug | A |
| PlaceboTablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up | Drug | B |
Primary outcome
Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores
Time frame: recorded during the last 7 days of treatment in each period
1 secondary outcome
Other glycemic, vascular, and mechanism-based biomarkers will be measured
Time frame: throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-741672 in people with Neuropathic Pain, run by Bristol-Myers Squibb at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores (time frame: recorded during the last 7 days of treatment in each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.