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

History of Changes

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:

MedlinePlus related topics: Peripheral Nerve Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

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:


Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Pregabalin Analgesics Anticonvulsants	Calcium Channel Blockers Cardiovascular Agents Central Nervous System Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

To Top