Diabetic NeuropathyPhase 1NCT01820715
A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain
A Phase 1 study testing 600㎍ of DA-3030 Injection in people with Diabetic Neuropathy, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- 600㎍ of DA-3030 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Apr 2013
- Phase
- Phase 1
- 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
- 20≤ Age ≤ 70
- Diagnosed with 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 mor for 24 hours evaluated with 11-point Likert scale
Who cannot join
- Neuropathic pain due to other causes
- Another stronger pain other than neuropathic pain
- Abnormality in blood pressure, weight
- Positive reaction in HIV, HBV or HCV
- A medical history of mental illness within 6 months
- The grade of BDI(Beck Depression Inventory) exceeds 21 points
- History of drug/alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of the DA-3030 Injection to Evaluate Its Safety and Explore the Efficacy for Diabetic Neuropathic Pain
A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.
- Conditions
- Diabetic Neuropathy
- Being tested
- 600㎍ of DA-3030 Injection, Placebo
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600㎍ of DA-3030 InjectionDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 600㎍ of DA-3030 Injection | Experimental | 600㎍ of DA-3030 is injected once a day, for 5 continuous days. Receives: Drug: 600㎍ of DA-3030 Injection |
| Placebo | Placebo comparator | Placebo(a salin drip) is injected once a day, for 5 continuous days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal score of vital signs measured by following methods: two-sample t-test, Wilcoxon rank sum test, Paired t- test, Wilcoxon signed rank test, McNemar test, Chi-squared test, or/and Fisher's exact test
Measured: 12 Weeks
Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event
Measured: 12 weeks
Secondary outcomes (3)
Average pain score
Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain)
Measured: 12 Weeks
Most severe pain score
Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain)
Measured: 12 weeks
overnight pain score
Measuring how much the subject feels pain last night on a scale of one to ten (no pain - most severe pain)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startJun 2010
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoo Heon Ahn, M.D., Ph.D., Principal investigator, Hanyang UniversityBong Yeon Cha, M.D., Ph.D., Principal investigator, Seoul St. Mary's Hospital, The Catholic University of KoreaKyung Soo Ko, M.D, Ph.D., Principal investigator, Inje UniversityTae Sun Park, M.D., Ph.D., Principal investigator, Chonbuk National University HospitalYoung Soo Park, M.D.,Ph.D., Principal investigator, Hanyang University Guri HospitalChoon Hee Chung, M.D., Ph.D., Principal investigator, Wonju Christian HospitalIn Joo Kim, M.D., Ph.D., Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820715
- Sponsor's protocol ID
- DA3030_DN_I (Version 3.4)
- Status last verified
- Aug 2013
- First submitted
- 15 Mar 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the DA-3030 Injection to Evaluate Its Safety and Explore the Efficacy for Diabetic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01820715
- Acronym / sponsor ID
- DA3030_DN_I (Version 3.4)
- Conditions
- Diabetic Neuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- First posted
- 29 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.
A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 600㎍ of DA-3030 Injection | Experimental | Drug: 600㎍ of DA-3030 Injection600㎍ of DA-3030 is injected once a day, for 5 continuous days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo(a salin drip) is injected once a day, for 5 continuous days. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20≤ Age ≤ 70
- Diagnosed with 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 mor for 24 hours evaluated with 11-point Likert scale
Key exclusion criteria (7 listed)
- Neuropathic pain due to other causes
- Another stronger pain other than neuropathic pain
- Abnormality in blood pressure, weight
- Positive reaction in HIV, HBV or HCV
- A medical history of mental illness within 6 months
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 |
|---|---|---|
| 600㎍ of DA-3030 Injection | Drug | 600㎍ of DA-3030 Injection |
| Placebo | Drug | Placebo |
Primary outcome
Abnormal score of vital signs measured by following methods: two-sample t-test, Wilcoxon rank sum test, Paired t- test, Wilcoxon signed rank test, McNemar test, Chi-squared test, or/and Fisher's exact test
Time frame: 12 Weeks
Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event
Time frame: 12 weeks
3 secondary outcomes
Average pain score
Time frame: 12 Weeks
Most severe pain score
Time frame: 12 weeks
overnight pain score
Time frame: 12 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 13 Aug 2013.
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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.
Yoo Heon Ahn, M.D., Ph.D. principal investigator
Hanyang University
Bong Yeon Cha, M.D., Ph.D. principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
Kyung Soo Ko, M.D, Ph.D. principal investigator
Inje University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 600㎍ of DA-3030 Injection in people with Diabetic Neuropathy, run by Dong-A Pharmaceutical 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 7 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 13 Aug 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Abnormal score of vital signs measured by following methods: two-sample t-test, Wilcoxon rank sum test, Paired t- test, Wilcoxon signed rank test, McNemar test, Chi-squared test, or/and Fisher's exact test (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2013.