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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01504412
First received: January 3, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Pain
Diabetic Peripheral Neuropathy
Drug: DS-5565
Drug: Placebo
Drug: Pregabalin capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change in average daily pain score as determined by the participants entries in daily pain diary [ Time Frame: Baseline to 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in short form McGill Pain Questionnaire [ Time Frame: Baseline to week 7 ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DS-5565 Low Dose
DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
Drug: DS-5565
Oral tablets administered twice daily
Experimental: DS-5565 Middle Dose
DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
Drug: DS-5565
Oral tablets administered twice daily
Experimental: DS-5565 High Dose
DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
Drug: DS-5565
Oral tablets administered twice daily
Placebo Comparator: Placebo
DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
Drug: Placebo
DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day
Active Comparator: Pregabalin
Pregabalin capsules 300mg/day administered in 2 doses
Drug: Pregabalin capsules
Pregabalin oral capsules 150 mg administered twice a day

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504412

Locations
Japan
Tokyo, Japan
Korea, Republic of
Seoul, Korea, Republic of
Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01504412     History of Changes
Other Study ID Numbers: DS5565-A-J202
Study First Received: January 3, 2012
Last Updated: December 11, 2013
Health Authority: Korea: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Taiwan : Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Pain
Diabetic Peripheral Neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 22, 2014