Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy

Phase 2

Completed

• Conditions: Diabetic Peripheral Neuropathy; Pain
• Interventions: Drug: Pregabalin capsules; Drug: Placebo; Drug: DS-5565

• Registration Number: NCT01504412
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2020-02-04
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-16
• Last Update Submitted: 2020-03-16
• Results First Posted: 2020-03-18
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Type 1 or Type 2 diabetes mellitus
• Painful distal symmetric polyneuropathy
• Average daily pain score is great than or equal to 4

Exclusion Criteria

• HbA1c greater than 9.0

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin	Pregabalin capsules	Pregabalin capsules 300mg/day administered in 2 doses
Placebo	Placebo	DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
DS-5565 High Dose	DS-5565	DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
DS-5565 Low Dose	DS-5565	DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
DS-5565 Middle Dose	DS-5565	DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.

Primary Outcome Measures

Name	Time	Method
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	Baseline to Week 7 postdose	The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	at Week 7 postdose	The Short Form-McGill Pain Questionnaire (SF-MPQ) Visual Analog Scale (VAS) is reported. For VAS, participants rated pain intensity on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.; Greater mean changes (improvements) in SF-MPQ indicated better outcomes.