Diabetic NeuropathyPhase 3NCT01863810
Efficacy and Safety of KW21052 Compared to Lyrica in the Diabetic Patients With Neuropathic Pain
A Phase 3 study testing KW21052, Lyrica and Lyrica (low dose) in people with Diabetic Neuropathy, run by KunWha Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life and increasing societal costs. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- KW21052, Lyrica and Lyrica (low dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Oct 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 and 2 diabetic patients
- Patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy
- 40mm and more on VAS
- 4 and more on NRS
- Informed consented patients
Who cannot join
- Participating in another clinical trial
- Pregnancy or lactating
- Sensitivity to pregabalin
- Significant underlying disease or disorders
- Prohibited concomitant medications
- Significant laboratory abnormalities
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center
Seoul
Kwang-Kuk Kim, M.D., Ph.D., kkkim@amc.seoul.kr
About this study
Official title: Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KW21052 for 8 Weeks Compared to Pregabalin (Lyrica) in the Diabetic Patients With Neuropathic Pain
Diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to manage the chronic neuropathic pain in diabetic patients. This study is designed as a randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th week of intervention is inferior to that of Lyrica.
Read the detailed description
Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.
- Conditions
- Diabetic Neuropathy
- Being tested
- KW21052, Lyrica, Lyrica (low dose), Placebo of KW21052, Placebo of Lyrica
- Keywords
- Diabetic Neuropathy, Neuropathic Pain, Pregabalin
- Medical subject headings
- Diabetic Neuropathies, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW21052Drug
1 Tablet contains 300mg of pregabalin. Oral, once a day, for 8 weeks.
LyricaDrug
1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks.
Lyrica (low dose)Drug
1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.
Placebo of KW21052Drug
Oral,once a day, for 8 weeks
Placebo of LyricaDrug
Oral, twice a day, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| KW21052 | Experimental | This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with KW21052 300mg and Placebo of Lyrica for intervention period of 8 weeks. Receives: Drug: KW21052; Drug: Lyrica (low dose); Drug: Placebo of Lyrica |
| LYRICA | Active comparator | This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with Lyrica 300mg (150mg bid) and Placebo of KW21052 300mg for intervention period of 8 weeks. Receives: Drug: Lyrica; Drug: Lyrica (low dose); Drug: Placebo of KW21052 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale (NRS)
Measured: After 8 weeks of intervention
Secondary outcomes (6)
Change on on the numerical pain rating scale (NRS)
Measured: From baseline to 8th week of intervention
Response rate
Measured: From baseline to 4th and 8th week of intervention
Clinical Global Impression of Change (CGIC)
Measured: After 8 weeks of intervention
Improved quality of life (QoL)
Measured: After 4 and 8 weeks of intervention
Drug compliance
Measured: During 8 weeks of intervention
Adverse events
Measured: Every clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KunWha Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kwang-Kuk Kim, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863810
- Sponsor's protocol ID
- KW21052_P3
- Status last verified
- May 2013
- First submitted
- 23 May 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KW21052 for 8 Weeks Compared to Pregabalin (Lyrica) in the Diabetic Patients With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01863810
- Acronym / sponsor ID
- KW21052_P3
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetic Neuropathy, Neuropathic Pain, Pregabalin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- KunWha Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 29 May 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.
Diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to manage the chronic neuropathic pain in diabetic patients. This study is designed as a randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th week of intervention is inferior to that of Lyrica.
Detailed description
Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.
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 |
|---|---|---|
| KW21052 | Experimental | Drug: KW21052, Drug: Lyrica (low dose), Drug: Placebo of LyricaThis arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with KW21052 300mg and Placebo of Lyrica for intervention period of 8 weeks. |
| LYRICA | Active comparator | Drug: Lyrica, Drug: Lyrica (low dose), Drug: Placebo of KW21052This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with Lyrica 300mg (150mg bid) and Placebo of KW21052 300mg for intervention period of 8 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 and 2 diabetic patients
- Patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy
- 40mm and more on VAS
- 4 and more on NRS
- Informed consented patients
Key exclusion criteria (6 listed)
- Participating in another clinical trial
- Pregnancy or lactating
- Sensitivity to pregabalin
- Significant underlying disease or disorders
- Prohibited concomitant medications
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 |
|---|---|---|
| KW210521 Tablet contains 300mg of pregabalin. Oral, once a day, for 8 weeks. | Drug | KW21052 |
| Lyrica1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks. | Drug | LYRICA |
| Lyrica (low dose)1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week. | Drug | KW21052, LYRICA |
| Placebo of KW21052Oral,once a day, for 8 weeks | Drug | LYRICA |
| Placebo of LyricaOral, twice a day, for 8 weeks. | Drug | KW21052 |
Primary outcome
Numerical pain rating scale (NRS)
Time frame: After 8 weeks of intervention
6 secondary outcomes
Change on on the numerical pain rating scale (NRS)
Time frame: From baseline to 8th week of intervention
Response rate
Time frame: From baseline to 4th and 8th week of intervention
Clinical Global Impression of Change (CGIC)
Time frame: After 8 weeks of intervention
Improved quality of life (QoL)
Time frame: After 4 and 8 weeks of intervention
Drug compliance
Time frame: During 8 weeks of intervention
Adverse events
Time frame: Every clinic visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 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.
Kwang-Kuk Kim, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KW21052, Lyrica and Lyrica (low dose) in people with Diabetic Neuropathy, run by KunWha 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 6 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: status not confirmed, as of the sponsor's last update on 29 May 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hae-kwan Eo (82 2 2047 7789, hkeo@kunwha.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale (NRS) (time frame: After 8 weeks of intervention). 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 29 May 2013; AzTrials last refreshed its copy on 8 Nov 2026.