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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023042-70 | EudraCT Number |
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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).
Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-954561 40mg or 80mg | Other | BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over) |
|
| Arm 2: BMS-954561 150mg or 300mg | Other | BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over) |
|
| Arm 3: Pregabalin 100mg | Other | Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-954561 | Drug |
| ||
| Pregabalin |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Achieve Clinical Research, Llc | Birmingham | Alabama | 35216 | United States | ||
| Arizona Research Center |
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| Drug |
|
| Placebo matching BMS-954561 | Drug |
|
| Placebo matching Pregabalin | Drug |
|
| 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 |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Torrance Clinical Research | Lomita | California | 90717 | United States |
| Office Of Richard S. Cherlin, Md | Los Gatos | California | 95032 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Brain Matters Research | Delray Beach | Florida | 33445 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Compass Research, Llc | Orlando | Florida | 32806 | United States |
| Comprehensive Clinical Development, Inc. | St. Petersburg | Florida | 33716 | United States |
| Northwest Neurology Ltd. | Lake Barrington | Illinois | 60010 | United States |
| Commonwealth Biomedical Research, Llc | Madisonville | Kentucky | 42431 | United States |
| The Center For Pharmaceutical Research. Pc | Kansas City | Missouri | 64114 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Physicians East P.A. | Greenville | North Carolina | 27834 | United States |
| Pmg Research Of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Radiant Research, Inc. | Akron | Ohio | 44311 | United States |
| Neurology & Neuroscience Center Of Ohio | Toledo | Ohio | 43623 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Dallas Diabetes & Endocrine Center | Dallas | Texas | 75230 | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | United States |
| Local Institution | Dijon | 21079 | France |
| Local Institution | Nantes | 44093 | France |
| Local Institution | Nice | 06003 | France |
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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