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

February 11, 2011
November 28, 2012
March 2011
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01314222 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Diabetic Peripheral Neuropathic Pain (DPNP)
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)

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Peripheral Neuropathic Pain
  • 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: 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: 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)
  • Drug: Placebo matching Pregabalin
    Capsule, Oral, 0mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
  • 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)

    Interventions:
    • Drug: BMS-954561
    • Drug: Placebo matching BMS-954561
  • 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)

    Interventions:
    • Drug: BMS-954561
    • Drug: Placebo matching BMS-954561
  • Arm 3: Pregabalin 100mg

    Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID

    Active to Placebo or Placebo to Active (cross-over)

    Interventions:
    • Drug: Pregabalin
    • Drug: Placebo matching Pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
July 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT01314222
CN169-001, 2010-023042-70
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP