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Completed

NCT Number: NCT01504412

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

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.

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Key information

Conditions

Pain Diabetic Peripheral Neuropathy Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DS-5565

Drug

Oral tablets administered twice daily

Placebo

Drug

DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day

pregabalin capsules

Drug

Pregabalin oral capsules 150 mg administered twice a day

Primary outcomes

  1. Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy

    Time frame: 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 outcomes

  1. Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

An Asian, Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Pregabalin-controlled, Dose-finding Study of DS-5565 in Patients With Pain Associated With Diabetic Peripheral Neuropathy

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 5, 2012
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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