Neuropathic PainPhase 4NCT05624853
A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain
A Phase 4 study testing pregabalin sustained release tablet and pregabalin immediate release capsule in people with Neuropathic Pain and Diabetes Mellitus, Type 2, run by Yuhan Corporation at 8 sites in South Korea.
Trial summary
This study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Neuropathic Pain, Diabetes Mellitus, Type 2
- What is being tested?
- pregabalin sustained release tablet and pregabalin immediate release capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 12 May 2020to 20 Dec 2022
- Phase
- Phase 4
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 19 years, < 75 years
- VAS score for diabetic peripheral neuropathy pain ≥ 30
- Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks
- Type II DM patient and HbA1c ≤ 10 %
- Written informed consent
Who cannot join
- Patient with hypersensitivity to pregabalin
- Patient on anti-epileptic drugs
- Patients with pain caused by other factors than diabetic peripheral neuropathy
- Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening
- AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
- Drug-abusing patient
Show all 10Show fewer
- Severe depression or uncontrolled abnormal mood and behavioral changes
- Pregnant and breast-feeding woman
- Patients who participated in other clinical trials for investigational products within 30 days of screening
- Patients deemed to be ineligible to participate in the trial by investigator
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Catholic University of Korea's Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
Inje University Haeundae Paik Hospital
Busan, 48108
Kosin University Gospel Hospital
Busan, 49267
Dankook University Hospital
Cheonan, Chungcheongnam-do, 31116
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
Chungnam National University Hospital
Daejeon, 35015
Daejeon Eulji Medical Center, Eulji University
Daejeon, 35233
Chungnam National University Sejong Hospital
Sejong, 30099
About this study
This study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain.
- Conditions
- Neuropathic Pain, Diabetes Mellitus, Type 2
- Being tested
- pregabalin sustained release tablet, pregabalin immediate release capsule
- Keywords
- pregabalin sustained release tablet
- Medical subject headings
- Neuralgia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalin sustained release tabletDrug
pregabalin sustained release tablet 150mg qd for 8weeks
pregabalin immediate release capsuleDrug
pregabalin immediate release capsule 75mg bid for 8weeks
| Study group | Role | What they receive |
|---|---|---|
| pregabalin sustained release tablet | Experimental | pregabalin sustained release tablet 150mg qd for 8weeks Receives: Drug: pregabalin sustained release tablet |
| pregabalin immediate release capsule | Active comparator | pregabalin immediate release capsule 75mg bid for 8weeks Receives: Drug: pregabalin immediate release capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 8 in Visual Analogue Scale(VAS)
Measured: Baseline/Week 8
Secondary outcomes (7)
Change from baseline to week 8 in Quality of Life(EQ-5D)
Measured: Baseline/Week 8
Change from baseline to week 8 in Patients Global Impression of Change(PGIC)
Measured: Baseline/Week 8
Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)
Measured: Baseline/Week 8
Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS)
Measured: Baseline/Week 8
Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8)
Measured: Baseline/Week 8
Dose and frequency of Rescue medication(Acetaminophen)
Measured: Baseline/Week 8
Number and proportion of subjects with adverse event
Measured: Baseline/Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start12 May 2020
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
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 Neuropathic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bon Jeong Ku, Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624853
- Sponsor's protocol ID
- YMC042
- Status last verified
- Oct 2023
- First submitted
- 14 Nov 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joung KH, Kim TN, Ku EJ, Lee SS, Yoo WS, Park KS, Kwon SK, Ku BJ. A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release pregabalin with immediate-release pregabalin in type 2 diabetic patients with peripheral neuropathic pain. J Diabetes Complications. 2024 Aug;38(8):108809. doi: 10.1016/j.jdiacomp.2024.108809. Epub 2024 Jul 14.
PubMed 39018898
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05624853
- Acronym / sponsor ID
- YMC042
- Conditions
- Neuropathic Pain, Diabetes Mellitus, Type 2
- Keywords
- pregabalin sustained release tablet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 May 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 22 Nov 2022 (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.
This study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregabalin sustained release tablet | Experimental | Drug: pregabalin sustained release tabletpregabalin sustained release tablet 150mg qd for 8weeks |
| pregabalin immediate release capsule | Active comparator | Drug: pregabalin immediate release capsulepregabalin immediate release capsule 75mg bid for 8weeks |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 19 years, < 75 years
- VAS score for diabetic peripheral neuropathy pain ≥ 30
- Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks
- Type II DM patient and HbA1c ≤ 10 %
- Written informed consent
Key exclusion criteria (10 listed)
- Patient with hypersensitivity to pregabalin
- Patient on anti-epileptic drugs
- Patients with pain caused by other factors than diabetic peripheral neuropathy
- Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening
- AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
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 |
|---|---|---|
| pregabalin sustained release tabletpregabalin sustained release tablet 150mg qd for 8weeks | Drug | pregabalin sustained release tablet |
| pregabalin immediate release capsulepregabalin immediate release capsule 75mg bid for 8weeks | Drug | pregabalin immediate release capsule |
Primary outcome
Change from baseline to week 8 in Visual Analogue Scale(VAS)
Time frame: Baseline/Week 8
7 secondary outcomes
Change from baseline to week 8 in Quality of Life(EQ-5D)
Time frame: Baseline/Week 8
Change from baseline to week 8 in Patients Global Impression of Change(PGIC)
Time frame: Baseline/Week 8
Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)
Time frame: Baseline/Week 8
Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS)
Time frame: Baseline/Week 8
Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8)
Time frame: Baseline/Week 8
Dose and frequency of Rescue medication(Acetaminophen)
Time frame: Baseline/Week 8
Number and proportion of subjects with adverse event
Time frame: Baseline/Week 8
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 23 Oct 2023.
- Derived from this study: PubMed 39018898Joung KH, Kim TN, Ku EJ, Lee SS, Yoo WS, Park KS, Kwon SK, Ku BJ. A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release pregabalin with immediate-release pregabalin in type 2 diabetic patients with peripheral neuropathic pain. J Diabetes Complications. 2024 Aug;38(8):108809. doi: 10.1016/j.jdiacomp.2024.108809. Epub 2024 Jul 14.
- Individual participant dataSharing planned: No
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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.
Bon Jeong Ku principal investigator
Chungnam National University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pregabalin sustained release tablet and pregabalin immediate release capsule in people with Neuropathic Pain and Diabetes Mellitus, Type 2, run by Yuhan Corporation at 8 sites 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 10 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline to week 8 in Visual Analogue Scale(VAS) (time frame: Baseline/Week 8). 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 NCT05624853, 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 23 Oct 2023.