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

NCT01504412 | Completed Phase 2 Results

• 1 other identifier: DS5565-A-J202
• Study Type: interventional
• Target: 450
• Locations: 3 countries
• Sites: 3

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.

Conditions

Pain; Diabetic Peripheral Neuropathy

Keywords

Pain; Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy

  at Week 7 postdose

Study Arms (5)

DS-5565 Low Dose

EXPERIMENTAL

DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.

Drug: DS-5565

DS-5565 Middle Dose

EXPERIMENTAL

DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.

Drug: DS-5565

DS-5565 High Dose

EXPERIMENTAL

DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.

Drug: DS-5565

Placebo

PLACEBO COMPARATOR

DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.

Drug: Placebo

Pregabalin

ACTIVE COMPARATOR

Pregabalin capsules 300mg/day administered in 2 doses

Drug: Pregabalin capsules

Interventions

DS-5565 DRUG

Oral tablets administered twice daily

DS-5565 Low Dose

Placebo DRUG

DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day

Placebo

Pregabalin capsules DRUG

Pregabalin oral capsules 150 mg administered twice a day

Pregabalin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or Type 2 diabetes mellitus
• Painful distal symmetric polyneuropathy
• Average daily pain score is great than or equal to 4

You may not qualify if:

• HbA1c greater than 9.0

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (3)

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

Related Publications (1)

• Baba M, Kuroha M, Ohwada S, Murayama E, Matsui N. Results of Mirogabalin Treatment for Diabetic Peripheral Neuropathic Pain in Asian Subjects: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study. Pain Ther. 2020 Jun;9(1):261-278. doi: 10.1007/s40122-020-00156-6. Epub 2020 Feb 12.

  PMID: 32052264 DERIVED

MeSH Terms

Conditions

Pain

Interventions

mirogabalin; Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo, Inc.

dsclinicaltrial@daiichisankyo.co.jp

+81 362251111 (M-F 9-5 JST)

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 5, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 18, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

TW (1); KR (1); JP (1)