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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504412
• Other study ID #: DS5565-A-J202
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: March 2020
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Pain
• Peripheral Nervous System Diseases

Intervention

Drug:
• DS-5565
Oral tablets administered twice daily
• DS-5565
Oral tablets administered twice daily
• DS-5565
Oral tablets administered twice daily
• Placebo
DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day
• Pregabalin capsules
Pregabalin oral capsules 150 mg administered twice a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point [scale of 0 to 10] versus placebo.	Baseline to Week 7 postdose
Secondary	Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	The Short Form-McGill Pain Questionnaire (SF-MPQ) Visual Analog Scale (VAS) is reported. For VAS, participants rated pain intensity on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.; Greater mean changes (improvements) in SF-MPQ indicated better outcomes.	at Week 7 postdose