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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

January 3, 2012
December 11, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01504412 on ClinicalTrials.gov Archive Site
Change in short form McGill Pain Questionnaire [ Time Frame: Baseline to week 7 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuorpathy
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Pain
  • Diabetic Peripheral Neuropathy
  • Drug: DS-5565
    Oral tablets administered twice daily
  • Drug: Placebo
    DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day
  • Drug: Pregabalin capsules
    Pregabalin oral capsules 150 mg administered twice a day
  • Experimental: DS-5565 Low Dose
    DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
    Intervention: Drug: DS-5565
  • Experimental: DS-5565 Middle Dose
    DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
    Intervention: Drug: DS-5565
  • Experimental: DS-5565 High Dose
    DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
    Intervention: Drug: DS-5565
  • Placebo Comparator: Placebo
    DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
    Intervention: Drug: Placebo
  • Active Comparator: Pregabalin
    Pregabalin capsules 300mg/day administered in 2 doses
    Intervention: Drug: Pregabalin capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Taiwan
 
NCT01504412
DS5565-A-J202
Not Provided
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
Daiichi Sankyo Co., Ltd.
Not Provided
Not Provided
Daiichi Sankyo Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP