Diabetic Peripheral Neuropathic Pain (DPNP)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Diabetic Peripheral Neuropathic Pain

Treatments

Drug: Pregabalin
Drug: Placebo matching Pregabalin
Drug: Placebo matching BMS-954561
Drug: BMS-954561

Study type

Interventional

Funder types

Industry

Identifiers

NCT01314222
CN169-001
2010-023042-70 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

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

Enrollment

178 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

178 participants in 3 patient groups

Arm 1: BMS-954561 40mg or 80mg
Other group
Description:
BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over)
Treatment:
Drug: Placebo matching BMS-954561
Drug: BMS-954561
Arm 2: BMS-954561 150mg or 300mg
Other group
Description:
BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over)
Treatment:
Drug: Placebo matching BMS-954561
Drug: BMS-954561
Arm 3: Pregabalin 100mg
Other group
Description:
Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over)
Treatment:
Drug: Placebo matching Pregabalin
Drug: Pregabalin

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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