Diabetic Peripheral Neuropathic Pain (DPNP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01314222
First received: February 11, 2011
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Diabetic Peripheral Neuropathic Pain
Drug: BMS-954561
Drug: Pregabalin
Drug: Placebo matching BMS-954561
Drug: Placebo matching Pregabalin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Screening/Baseline Phase: Baseline ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 1 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 2 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 3 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 4 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 5 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 6 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 7 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 8 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 9 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 10 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 2 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 4 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 8 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 12 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 16 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 20 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 1 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 2 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 3 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 4 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 5 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 6 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 7 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 8 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 9 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 10 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 2 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 4 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 8 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 12 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 16 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 20 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Screening/Baseline Phase: Baseline ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 1 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 2 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 3 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 4 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 5 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 6 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 7 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 8 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 9 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Double-blind Treatment Phase: Week 10 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Open-Label Phase: Week 2 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Open-Label Phase: Week 4 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Open-Label Phase: Week 8 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Open-Label Phase: Week 12 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Open-Label Phase: Week 16 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Open-Label Phase: Week 20 ] [ Designated as safety issue: Yes ]

Enrollment: 178
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Capsule, Oral, 40mg or 80mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
Other Name: BMS-954561
Drug: Placebo matching BMS-954561
Capsule, Oral, 0mg, Three times daily (TID)
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
Capsule, Oral, 150mg or 300mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
Other Name: BMS-954561
Drug: Placebo matching BMS-954561
Capsule, Oral, 0mg, Three times daily (TID)
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
Capsule, Oral, 100mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
Other Name: Lyrica in double-blind + BMS-954561 in open-label
Drug: Placebo matching Pregabalin
Capsule, Oral, 0mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)

Detailed Description:

Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314222

Locations
United States, Alabama
Achieve Clinical Research, Llc
Birmingham, Alabama, United States, 35216
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Torrance Clinical Research
Lomita, California, United States, 90717
Office Of Richard S. Cherlin, Md
Los Gatos, California, United States, 95032
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, Llc
Orlando, Florida, United States, 32806
Comprehensive Clinical Development, Inc.
St Petersburg, Florida, United States, 33716
United States, Illinois
Northwest Neurology Ltd.
Lake Barrington, Illinois, United States, 60010
United States, Kentucky
Commonwealth Biomedical Research, Llc
Madisonville, Kentucky, United States, 42431
United States, Missouri
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, United States, 64114
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, New York
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, North Carolina
Physicians East P.A.
Greenville, North Carolina, United States, 27834
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research, Inc.
Akron, Ohio, United States, 44311
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, United States, 43623
United States, Tennessee
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
France
Local Institution
Dijon Cedex, France, 21079
Local Institution
Nantes Cedex 1, France, 44093
Local Institution
Nice Cedex 1, France, 06003
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01314222     History of Changes
Other Study ID Numbers: CN169-001, 2010-023042-70
Study First Received: February 11, 2011
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 11, 2014