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

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
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Active Comparator: Pregabalin
Pregabalin capsules 300mg/day administered in 2 doses
|
Drug: Pregabalin capsules
Pregabalin oral capsules 150 mg administered twice a day
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- Change in average daily pain score as determined by the participants entries in daily pain diary [ Time Frame: Baseline to 7 weeks ]
- Change in short form McGill Pain Questionnaire [ Time Frame: Baseline to week 7 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
Tokyo, Japan | |
Korea, Republic of | |
Seoul, Korea, Republic of | |
Taiwan | |
Taipei, Taiwan |
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 |