Diabetic NeuropathiesPhase 2NCT01813799

Study of DA-9801 to Treat Diabetic Neuropathic Pain

A Phase 2 study testing DA-9801 300mg, DA-9801 600mg and DA-9801 900mg in people with Diabetic Neuropathies, run by Dong-A ST Co., Ltd. at 1 site in South Korea.

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

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Diabetic Neuropathies
What is being tested?: DA-9801 300mg, DA-9801 600mg and DA-9801 900mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: 1 siteSouth Korea
Study dates: Nov 2011to Jul 2013
Phase: Phase 2
Are there results?: None posted in the registry

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

the age of 20 ~ 70
Type I or Type II Diabetes
HbA1c ≤11%
Patients with diabetic neuropathic pain for at least 3 months
Patients corresponding to average pain level of 4 points or more for 24 hours evaluated with 11-point Likert scale

Who cannot join

neuropathic pain due to other causes or another stronger pain other than neuropathic pain
abnormal in blood pressure, weight, ALT/AST, Serum creatinine
positive reaction in HIV, HBV, or HCV
experience of suicide try or Mental Illness Medical History
BDI(Beck Depression Inventory) grade exceeding 21 points chronic alcohol abuse history

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chonbuk National University Hospital
Jeonju, 561-712

Other trials in South Korea

About this study

Official title: A Multicenter, Placebo-controlled, Randomized, Double-blind, Phase II Clinical Trial With Diabetic Neuropathy Patients is Designed to Evaluate the Safety and Efficacy of the DA-9801 Tablet for Neuropathic Pain and to Decide Optimal Dose.

This is a Phase II dose-ranging study to evaluate the effectiveness and safety of DA-9801 in the treatment of pain associated with diabetic neuropathy. Subjects will receive either 300mg, 600mg, 900mg or placebo, three times daily for eight weeks. During treatment, pain score by Likert numerical rating scale, Patient Global Impression of Improvement (PGI-I) and Change in Clinical Global Impression(CGI)are accessed to evaluate the effectiveness.

Conditions: Diabetic Neuropathies
Being tested: DA-9801 300mg, DA-9801 600mg, DA-9801 900mg, Placebo
Keywords: Diabetic Neuropathies
Medical subject headings: Diabetic Neuropathies

What participants receive

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

DA-9801 300mgDrug
300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
DA-9801 600mgDrug
600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
DA-9801 900mgDrug
900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
PlaceboDrug
Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Study groups in NCT01813799
Study group	Role	What they receive
DA-9801 300mg	Experimental	Not described Receives: Drug: DA-9801 300mg
DA-9801 600mg	Experimental	Not described Receives: Drug: DA-9801 600mg
DA-9801 900mg	Experimental	Not described Receives: Drug: DA-9801 900mg
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.
Measured: 8 weeks

Secondary outcomes (6)

Inter-group difference in average 24-h pain intensity (Likert scale)
The mean value of the last one week since the date of visit was calculated to compare the difference between treatment groups.
Measured: 8 weeks
Most severe mean pain intensity (Likert Scale)
Subject records the most severe pain intensity for the past 24 hours in the patient diary at the same time every morning.
Measured: 4, 8 weeks
Overnight pain intensity (Likert Scale)
Subject records the overnight pain intensity during the previous night in the patient diary at the same time every morning.
Measured: 4, 8 weeks
Patient's Global Impression of improvement (1 point ~ 7 point)
Subject evaluated the level of symptom improvement during the visits after IP administration.
Measured: 4, 8 weeks
Clinical Global Impression of severity (1 point ~ 7 point)
Investigator evaluated the level of symptom severity when a subject visited the institution.
Measured: 4, 8 weeks
Average daily dose of acetaminophen
Subject records dose of acetaminophen during the past 24 hours in patient diary at the same time every
Measured: everyday(-2 weeks~0), everyday(0~8 weeks)

Timeline

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

Nov 2011Jul 2013

First posted19 Mar 2013 (estimated)
Study startNov 2011
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetic NeuropathiesStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01813799
Sponsor's protocol ID: DA9801_DN_II
Status last verified: Apr 2019
First submitted: 13 Mar 2013
Last updated: 16 Apr 2019
Results posted: No
Data monitoring committee: No

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?

See locations

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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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All Diabetic Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Placebo-controlled, Randomized, Double-blind, Phase II Clinical Trial With Diabetic Neuropathy Patients is Designed to Evaluate the Safety and Efficacy of the DA-9801 Tablet for Neuropathic Pain and to Decide Optimal Dose.
ClinicalTrials.gov ID: NCT01813799
Acronym / sponsor ID: DA9801_DN_II
Conditions: Diabetic Neuropathies
Keywords: Diabetic Neuropathies
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
Study start: Nov 2011 (actual)
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 19 Mar 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
DA-9801 300mg	Experimental	Drug: DA-9801 300mg
DA-9801 600mg	Experimental	Drug: DA-9801 600mg
DA-9801 900mg	Experimental	Drug: DA-9801 900mg
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

the age of 20 ~ 70
Type I or Type II Diabetes
HbA1c ≤11%
Patients with diabetic neuropathic pain for at least 3 months
Patients corresponding to average pain level of 4 points or more for 24 hours evaluated with 11-point Likert scale

Key exclusion criteria (5 listed)

neuropathic pain due to other causes or another stronger pain other than neuropathic pain
abnormal in blood pressure, weight, ALT/AST, Serum creatinine
positive reaction in HIV, HBV, or HCV
experience of suicide try or Mental Illness Medical History
BDI(Beck Depression Inventory) grade exceeding 21 points chronic alcohol abuse history

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
DA-9801 300mg300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.	Drug	DA-9801 300mg
DA-9801 600mg600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.	Drug	DA-9801 600mg
DA-9801 900mg900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.	Drug	DA-9801 900mg
PlaceboPlacebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.	Drug	Placebo

Primary outcome

Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
Time frame: 8 weeks
Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.

6 secondary outcomes

Inter-group difference in average 24-h pain intensity (Likert scale)
Time frame: 8 weeks
Most severe mean pain intensity (Likert Scale)
Time frame: 4, 8 weeks
Overnight pain intensity (Likert Scale)
Time frame: 4, 8 weeks
Patient's Global Impression of improvement (1 point ~ 7 point)
Time frame: 4, 8 weeks
Clinical Global Impression of severity (1 point ~ 7 point)
Time frame: 4, 8 weeks
Average daily dose of acetaminophen
Time frame: everyday(-2 weeks~0), everyday(0~8 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.

Related trials for Diabetic Neuropathies

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

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.

Bongyeon Cha, M.D. principal investigator

The Catholic University of Korea

Hyeok Sang Gwon, M.D. principal investigator

Catholic University Yeouido St. Mary's Hopspital

Inkyung Jeong, M.D. principal investigator

Gangdong Kyunghee University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DA-9801 300mg, DA-9801 600mg and DA-9801 900mg in people with Diabetic Neuropathies, run by Dong-A ST Co., Ltd. at 1 site in South Korea.

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 5 inclusion and 5 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Difference in average 24-h pain intensity (Likert scale) between before and after IP administration (time frame: 8 weeks). 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 NCT01813799.

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 16 Apr 2019.