Pain of MononeuropathyPhase 3NCT03221907
Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' in Peripheral Neuropathic Pain
A Phase 3 study testing GLA5PR GLARS-NF1 and Pregabalin in people with Pain of Mononeuropathy, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A multi-center, randomized, double-blind, parallel, active-controlled phase III clinical trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in peripheral neuropathic pain Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain of Mononeuropathy
- What is being tested?
- GLA5PR GLARS-NF1 and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2016to 8 Jan 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both male and female who are over 19-year-old
- patient whose pain scale is 4~9
- patient who has pain of mononeuropathy
Who cannot join
- patient whose CCr is <60ml/min
- patient who has other pain which is not from mononeuropathy
- patient who is going to have an operation during this study
- patient who has abnormal ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel, Active-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in Peripheral Neuropathic Pain
A multi-center, randomized, double-blind, parallel, active-controlled phase III clinical trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in peripheral neuropathic pain
- Conditions
- Pain of Mononeuropathy
- Being tested
- GLA5PR GLARS-NF1, GLA5PR GLARS-NF1 placebo, Pregabalin, Pregabalin placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLA5PR GLARS-NF1Drug
Pregabalin tablet
GLA5PR GLARS-NF1 placeboDrug
Also called placebo (for GLA5PR GLARS-NF1)
tablet manufactured to mimic GLA5PR GLARS-NF1
PregabalinDrug
Also called Lyrica
Pregabalin capsule
Pregabalin placeboDrug
Also called placebo (for pregablin)
tablet manufactured to mimic pregabalin capsule
| Study group | Role | What they receive |
|---|---|---|
| GLA5PR GLARS-NF1 & Pregabalin placebo | Experimental | GLA5PR GLARS-NF1 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin placebo 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months Receives: Drug: GLA5PR GLARS-NF1; Drug: Pregabalin placebo |
| GLA5PR GLARS-NF1 placebo & Pregabalin | Active comparator | GLA5PR GLARS-NF1 placebo 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months Receives: Drug: GLA5PR GLARS-NF1 placebo; Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Pain Rating Scale
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start11 Apr 2016
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain of MononeuropathyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221907
- Sponsor's protocol ID
- DW1502-301
- Status last verified
- Mar 2019
- First submitted
- 11 Jul 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
Publications
Lee MK, Jeon Y, Choi SS, Lee PB, Kim YC, Suh JH, Sim SE, Song SO, Ko Y, Yu JM, Min K, Lee JH. Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial. Clin Ther. 2020 Dec;42(12):2266-2279. doi: 10.1016/j.clinthera.2020.10.009. Epub 2020 Nov 30.
PubMed 33272643
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel, Active-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03221907
- Acronym / sponsor ID
- DW1502-301
- Conditions
- Pain of Mononeuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 19 Jul 2017 (actual)
- 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-center, randomized, double-blind, parallel, active-controlled phase III clinical trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in peripheral neuropathic pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLA5PR GLARS-NF1 & Pregabalin placebo | Experimental | Drug: GLA5PR GLARS-NF1, Drug: Pregabalin placeboGLA5PR GLARS-NF1 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin placebo 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months |
| GLA5PR GLARS-NF1 placebo & Pregabalin | Active comparator | Drug: GLA5PR GLARS-NF1 placebo, Drug: PregabalinGLA5PR GLARS-NF1 placebo 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- both male and female who are over 19-year-old
- patient whose pain scale is 4~9
- patient who has pain of mononeuropathy
Key exclusion criteria (4 listed)
- patient whose CCr is <60ml/min
- patient who has other pain which is not from mononeuropathy
- patient who is going to have an operation during this study
- patient who has abnormal ECG
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 |
|---|---|---|
| GLA5PR GLARS-NF1Pregabalin tablet | Drug | GLA5PR GLARS-NF1 & Pregabalin placebo |
| GLA5PR GLARS-NF1 placeboAlso: placebo (for GLA5PR GLARS-NF1)tablet manufactured to mimic GLA5PR GLARS-NF1 | Drug | GLA5PR GLARS-NF1 placebo & Pregabalin |
| PregabalinAlso: LyricaPregabalin capsule | Drug | GLA5PR GLARS-NF1 placebo & Pregabalin |
| Pregabalin placeboAlso: placebo (for pregablin)tablet manufactured to mimic pregabalin capsule | Drug | GLA5PR GLARS-NF1 & Pregabalin placebo |
Primary outcome
Daily Pain Rating Scale
Time frame: 12-week
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 19 Mar 2019.
- Derived from this study: PubMed 33272643Lee MK, Jeon Y, Choi SS, Lee PB, Kim YC, Suh JH, Sim SE, Song SO, Ko Y, Yu JM, Min K, Lee JH. Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial. Clin Ther. 2020 Dec;42(12):2266-2279. doi: 10.1016/j.clinthera.2020.10.009. Epub 2020 Nov 30.
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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.
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 GLA5PR GLARS-NF1 and Pregabalin in people with Pain of Mononeuropathy, run by Daewon 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 3 inclusion and 4 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 19 Mar 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. 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?
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?
Daily Pain Rating Scale (time frame: 12-week). 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 NCT03221907, 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 19 Mar 2019.