PainPhase 2NCT01504412

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

A Phase 2 study testing DS-5565 and Pregabalin capsules in people with Pain and Diabetic Peripheral Neuropathy, run by Daiichi Sankyo Co., Ltd. at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Pain, Diabetic Peripheral Neuropathy
What is being tested?: DS-5565 and Pregabalin capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 450 participants
Where: 3 sitesin 3 countries
Study dates: Jan 2012to Jun 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

HbA1c greater than 9.0

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Japan1 site

Study site
Tokyo

Other trials in Japan

South Korea1 site

Study site
Seoul

Other trials in South Korea

Taiwan1 site

Study site
Taipei

Other trials in Taiwan

About this study

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

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
Being tested: DS-5565, Placebo, Pregabalin capsules
Keywords: Pain, Diabetic Peripheral Neuropathy
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01504412
Study group	Role	What they receive
DS-5565 Low Dose	Experimental	DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. Receives: 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. Receives: 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. Receives: Drug: DS-5565
Placebo	Placebo comparator	DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day. Receives: Drug: Placebo
Pregabalin	Active comparator	Pregabalin capsules 300mg/day administered in 2 doses Receives: Drug: Pregabalin capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: at Week 7 postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jun 2013

First posted5 Jan 2012 (estimated)
Study startJan 2012
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01504412
Sponsor's protocol ID: DS5565-A-J202
Status last verified: Mar 2020
First submitted: 3 Jan 2012
Last updated: 18 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

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.
PubMed 32052264

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01504412
Acronym / sponsor ID: DS5565-A-J202
Conditions: Pain, Diabetic Peripheral Neuropathy
Keywords: Pain, Diabetic Peripheral Neuropathy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 5 Jan 2012 (estimated)
Results: Posted 18 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
DS-5565 Low Dose	Experimental	Drug: DS-5565DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
DS-5565 Middle Dose	Experimental	Drug: DS-5565DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
DS-5565 High Dose	Experimental	Drug: DS-5565DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
Placebo	Placebo comparator	Drug: PlaceboDS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
Pregabalin	Active comparator	Drug: Pregabalin capsulesPregabalin capsules 300mg/day administered in 2 doses

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

HbA1c greater than 9.0

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DS-5565Oral tablets administered twice daily	Drug	DS-5565 Low Dose
DS-5565Oral tablets administered twice daily	Drug	DS-5565 Middle Dose
DS-5565Oral tablets administered twice daily	Drug	DS-5565 High Dose
PlaceboDS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day	Drug	Placebo
Pregabalin capsulesPregabalin oral capsules 150 mg administered twice a day	Drug	Pregabalin

Primary outcome

Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy
Time frame: Baseline to Week 7 postdose
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.

1 secondary outcome

Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy
Time frame: at Week 7 postdose

Results and safety

Results posted to the registry on 18 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	89	84
Pregabalin	87	75
DS-5565 10 mg/Day	90	86
DS-5565 20 mg/Day	94	75
DS-5565 30 mg/Day	90	77

Primary outcome: Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy

Time frame: Baseline to Week 7 postdose. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 88	Pregabalin n = 85	DS-5565 10 mg/Day n = 90	DS-5565 20 mg/Day n = 93	DS-5565 30 mg/Day n = 90
Baseline to Week 1	-0.59 (1.13)	-0.71 (1.29)	-0.69 (0.90)	-0.88 (1.32)	-0.60 (1.01)
Baseline to Week 2	-0.86 (1.36)	-0.92 (1.33)	-1.16 (1.06)	-1.21 (1.56)	-1.06 (1.28)
Baseline to Week 3	-1.05 (1.38)	-1.06 (1.29)	-1.32 (1.15)	-1.50 (1.68)	-1.35 (1.52)
Baseline to Week 4	-1.12 (1.47)	-1.29 (1.48)	-1.50 (1.22)	-1.65 (1.68)	-1.56 (1.53)
Baseline to Week 5	-1.28 (1.62)	-1.44 (1.56)	-1.62 (1.32)	-1.68 (1.80)	-1.47 (1.61)
Baseline to Week 6	-1.41 (1.68)	-1.40 (1.51)	-1.79 (1.31)	-1.78 (1.68)	-1.68 (1.50)
Baseline to Week 7	-1.50 (1.77)	-1.55 (1.77)	-1.82 (1.36)	-1.91 (1.77)	-1.75 (1.68)

Placebo vs DS-5565 10 mg/Day: Hazard Ratio (HR): -0.42 (95% CI -0.99 to 0.15), p = 0.1995, ANCOVA
Placebo vs DS-5565 20 mg/Day: Hazard Ratio (HR): -0.37 (95% CI -0.93 to 0.20), p = 0.2886, ANCOVA
Placebo vs DS-5565 30 mg/Day: Hazard Ratio (HR): -0.30 (95% CI -0.87 to 0.27), p = 0.4704, ANCOVA

Population analysed: Mean change in ADPS was assessed in the Full Analysis Set.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the time the Informed Consent Form was signed to 7 days after the last dose of study medication, approximately 18 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 88 (3.4%)	13 of 88 (14.8%)	0 of 88
Pregabalin	2 of 86 (2.3%)	28 of 86 (32.6%)	0 of 86
DS-5565 10 mg/Day	1 of 90 (1.1%)	18 of 90 (20%)	0 of 90
DS-5565 20 mg/Day	4 of 93 (4.3%)	38 of 93 (40.9%)	1 of 93
DS-5565 30 mg/Day	2 of 90 (2.2%)	42 of 90 (46.7%)	0 of 90

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32052264Baba 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.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DS-5565 and Pregabalin capsules in people with Pain and Diabetic Peripheral Neuropathy, run by Daiichi Sankyo Co., Ltd. at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy (time frame: Baseline to Week 7 postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01504412, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.