Diabetic Peripheral Neuropathic Pain (DPNP)
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Arm 1: BMS-954561 40mg or 80mg BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over) |
Drug: BMS-954561
Drug: Placebo matching BMS-954561
|
| Other: Arm 2: BMS-954561 150mg or 300mg BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over) |
Drug: BMS-954561
Drug: Placebo matching BMS-954561
|
| Other: Arm 3: Pregabalin 100mg Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over) |
Drug: Pregabalin
Drug: Placebo matching Pregabalin
|
Outcome Measures
Primary Outcome Measures
- The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. [Up to 10 weeks]
Secondary Outcome Measures
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Screening/Baseline Phase: Baseline]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 1]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 2]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 3]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 4]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 5]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 6]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 7]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 8]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 9]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Week 10]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Week 2]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Week 4]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Week 8]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Week 12]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Week 16]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Week 20]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 1]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 2]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 3]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 4]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 5]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 6]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 7]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 8]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 9]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Week 10]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Week 2]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Week 4]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Week 8]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Week 12]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Week 16]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Week 20]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Screening/Baseline Phase: Baseline]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 1]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 2]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 3]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 4]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 5]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 6]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 7]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 8]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 9]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Double-blind Treatment Phase: Week 10]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Week 2]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Week 4]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Week 8]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Week 12]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Week 16]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Week 20]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 6 months duration.
-
Score of ≥3 on Michigan Neuropathy Screening Instrument
-
The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
-
Based on patient diary information collected during the Screening/Baseline period, the patient has completed at least 5 of 7 daily diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale, in the week immediately prior to randomization (Baseline Visit).
-
Male or female, 18-85 years of age.
Exclusion Criteria:
-
History of complete lack of response to Pregabalin (at least 300 mg qd for 4 weeks) or Gabapentin (at least 1800 mg qd for 4 weeks).
-
Other severe pain that may potentially confound pain assessment.
-
Hemoglobin A1c > 9%
-
Hemoglobin ≤ 9 g/dL
-
Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 50ml/min/1.73m2
-
Patients who have been on a stable dose of anticonvulsant, anticholinergic, diabetic meds, nicotine replacements, or any other smoking cessation meds for <4 weeks prior to randomization. Patients who are on stable doses for ≥ 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.
-
Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids or antidepressants). Patients are allowed to participate if on a stable dose of for at least 4 weeks prior to randomization (Day1) and should remain stable during study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Achieve Clinical Research, Llc | Birmingham | Alabama | United States | 35216 |
| 2 | Arizona Research Center | Phoenix | Arizona | United States | 85023 |
| 3 | Torrance Clinical Research | Lomita | California | United States | 90717 |
| 4 | Office Of Richard S. Cherlin, Md | Los Gatos | California | United States | 95032 |
| 5 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
| 6 | Brain Matters Research | Delray Beach | Florida | United States | 33445 |
| 7 | Renstar Medical Research | Ocala | Florida | United States | 34471 |
| 8 | Compass Research, Llc | Orlando | Florida | United States | 32806 |
| 9 | Comprehensive Clinical Development, Inc. | St Petersburg | Florida | United States | 33716 |
| 10 | Northwest Neurology Ltd. | Lake Barrington | Illinois | United States | 60010 |
| 11 | Commonwealth Biomedical Research, Llc | Madisonville | Kentucky | United States | 42431 |
| 12 | The Center For Pharmaceutical Research. Pc | Kansas City | Missouri | United States | 64114 |
| 13 | Mercy Health Research | St. Louis | Missouri | United States | 63141 |
| 14 | Finger Lakes Clinical Research | Rochester | New York | United States | 14618 |
| 15 | Physicians East P.A. | Greenville | North Carolina | United States | 27834 |
| 16 | Pmg Research Of Winston-Salem | Winston-Salem | North Carolina | United States | 27103 |
| 17 | Radiant Research, Inc. | Akron | Ohio | United States | 44311 |
| 18 | Neurology & Neuroscience Center Of Ohio | Toledo | Ohio | United States | 43623 |
| 19 | Clinical Research Associates, Inc. | Nashville | Tennessee | United States | 37203 |
| 20 | Dallas Diabetes & Endocrine Center | Dallas | Texas | United States | 75230 |
| 21 | R/D Clinical Research, Inc. | Lake Jackson | Texas | United States | 77566 |
| 22 | Local Institution | Dijon Cedex | France | 21079 | |
| 23 | Local Institution | Nantes Cedex 1 | France | 44093 | |
| 24 | Local Institution | Nice Cedex 1 | France | 06003 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CN169-001
- 2010-023042-70