Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT01474772
• Date of registration: 15/11/2011
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
• Scientific title: A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking
• Date of first enrolment: October 2011
• Target sample size: 217
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01474772
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Czech Republic, Czechia, South Africa, Sweden, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men or women who are at least 18 years old.

- Diagnosis of painful diabetic peripheral neuropathy.

- Pain on walking.

Exclusion Criteria:

- Inability to walk 50 feet on a flat surface.

- Pain on walking due to conditions other than diabetic peripheral neuropathy.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetic Peripheral Neuropathy

Intervention(s)

Other: placebo

Drug: Pregabalin

Primary Outcome(s)

Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Secondary Outcome(s)

BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6) [Time Frame: End of Period 1 (V6)]

BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) [Time Frame: End of Period (includes both Visits 6 and 11)]

Secondary ID(s)

2011-003266-32

A0081269

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/11/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01474772