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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01504412

First Posted: January 5, 2012

Last Update Posted: December 12, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

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 Intervention Model: Parallel Assignment Masking: Double (Participant, 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. ( Daiichi Sankyo Co., Ltd. ):

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 ]

Secondary Outcome Measures:

Change in short form McGill Pain Questionnaire [ Time Frame: Baseline to week 7 ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504412

Locations


Japan

Tokyo, Japan
Korea, Republic of

Seoul, Korea, Republic of
Taiwan

Taipei, Taiwan

Sponsors and Collaborators

Daiichi Sankyo Co., Ltd.

More Information


Responsible Party:	Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01504412 History of Changes
Other Study ID Numbers:	DS5565-A-J202
First Submitted:	January 3, 2012
First Posted:	January 5, 2012
Last Update Posted:	December 12, 2013
Last Verified:	December 2013

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):


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 Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs

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