Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Browse trials for

• Peripheral Nervous System Diseases 1,003
• Neuralgia 1,287

Keywords

• Diabetic Peripheral Neuropathy
• Neuropathic Pain

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 226 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Lead sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 65 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Study arms

• Experimental
  ADL5859

  2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days

  Drug: ADL5859

• Active comparator
  Duloxetine

  2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days

  Drug: Duloxetine · Drug: Placebo

• Placebo comparator
  Placebo

  2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days

  Drug: Placebo

Interventions

• DrugADL5859
• DrugDuloxetine

  Also known as: Cymbalta

• DrugPlacebo

Primary outcomes

1. Change From Baseline in Mean Numeric Pain Rating Scale (NPRS) Score

   The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment group as a main factor and baseline NPRS score as a covariate. Change from Baseline = NPRS at baseline - NPRS at Week 4; a positive number in the LS mean indicates a reduction in pain intensity from baseline.

   Time frame: Baseline, Week 4

Secondary outcomes

1. Percentage of Responders

   A responder was defined as a participant who showed a reduction in average pain (as measured by NPRS) of at least 30% from baseline to Week 4. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The percentage of participants who qualified as responders is presented per treatment arm.

   Time frame: Baseline, Week 4

2. Patient Global Impression of Change (PGIC)

   PGIC is a participant-rated instrument that measures the change in the participant's overall status for the previous 2 weeks based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The number of participants in each category is presented.

   Time frame: Week 4

3. Change in Sleep Interference Scale (SIS) From Baseline

   Sleep Interference was assessed on an 11-point Numeric Rating Scale where a score of 0 indicated "pain did not interfere with sleep" and a score of 10 indicated "pain completely interfered with sleep". Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2, and 3 because a participant could have had multiple visits during Month 1, 2, and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. LS means were calculated using ANCOVA with treatment group as a main factor and baseline SIS score as a covariate. Change from baseline = SIS score at baseline - SIS score at Week 4.

   Time frame: Baseline, Week 4

4. Change From Baseline in the Evening Assessment of the 24-hour Overall Mean Pain Intensity Score

   At each of the evening pain assessments, participants assessed their overall pain intensity over the preceding 24 hours using NPRS. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained at Baseline and Week 4. Change from baseline = NPRS at baseline - NPRS at Week 4.

   Time frame: Baseline, Week 4

5. Change From Baseline in NPRS at Rest in the Clinic

   The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken while the participant was at rest. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.

   Time frame: Baseline, Week 1, Week 2, Week 3, Week 4

6. Change From Baseline in NPRS After Walking 50 Feet in the Clinic

   The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken after the participant walked 50 feet in the clinic. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.

   Time frame: Baseline, Week 1, Week 2, Week 3, Week 4

Baseline characteristics