DS-5565 Asian Phase II study

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000403

Enrollment

400

Registered

2012-04-16

Start date

2012-06-19

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Randomized to DS-5565 10mg group, DS-5565 20mg group, DS-5565 30mg group, Placebo group, Pregabalin group (1:1:1:1:1)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Type 1 or type 2 diabetes mellitus - Painful distal symmetric polyneuropathy - Average daily pain score = 4

Exclusion criteria

Exclusion criteria: HbA1c (National Glycohemoglobin Standardization Program) > 9.0%

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 7 in average daily pain score (ADPS), based on entries in patients' daily pain diaries.	—

Secondary

Measure	Time frame
in Short Form McGill Pain Questionnaire etc	—

Countries

Korea, Republic of

Contacts

Public ContactKyung Soo Ko

Inje University Sanggye Paik Hospital

Outcome results