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

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ClinicalTrials.gov Identifier: NCT01504412
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Change in short form McGill Pain Questionnaire [ Time Frame: Baseline to week 7 ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT01504412     History of Changes
Other Study ID Numbers: DS5565-A-J202
First Posted: January 5, 2012    Key Record Dates
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