Pain, NeuropathicNCT03691038
Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin
A study testing Pregabalin 75mg bid and Pregabalin 25mg, 50mg in people with Pain, Neuropathic, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to propose a new flexible dose regimen starting from 75mg using the low dose pregabalin 25 mg and 50 mg comparing the side effect and compliance with the conventional flexible dose regimen staring from 150mg using the pregabalin 75mg. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Pain, Neuropathic
- What is being tested?
- Pregabalin 75mg bid and Pregabalin 25mg, 50mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Oct 2018to 30 Oct 2019
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain score NRS ≥3 Patients complaining of neuropathic pain (except neuropathic pain due to chemotherapy)
- Adult patients aged 19 to 85 years
- Patients who pre-agreed to the study
Who cannot join
- Patients complaining of severe pain (NRS ≥ 8)
- Creatinine clearance of <30 mL / min, the liver was more than 3 times normal
- Patients complaining of dizziness, patients with definite orthostatic hypotension
- Pregnant or lactating patients
- Patients who previously experienced side effects after administration pregabalin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Conventional Flexible Dose Regimen of Pregabalin and New Flexible Dose Regimen of Pregabalin Using Low Dose: A Randomized Controlled Trial
The purpose of this study is to propose a new flexible dose regimen starting from 75mg using the low dose pregabalin 25 mg and 50 mg comparing the side effect and compliance with the conventional flexible dose regimen staring from 150mg using the pregabalin 75mg.
Read the detailed description
Pregabalin has been shown to be effective as a first-line medication for neuropathic pain but it appears to have several side effects such as dizziness, drowsiness, and edema, which lowers compliance with medications. A way to reduce side effects is the flexible dose regimen, which reaches the target dose to treat the drug. The proposed flexible dose regimen is a regimen that begins with twice the prevalence of 75 mg. However, dizziness is the most common side effect up to 20% in conventional flexible dose regimen. Therefore, the aim of this study was to propose a new flexible regimen starting at a dose less than the existing dose and to compare compliance with pregabaline according to both methods
- Conditions
- Pain, Neuropathic
- Being tested
- Pregabalin 75mg bid, Pregabalin 25mg, 50mg
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 75mg bidDrug
Also called Conventional regimen
Through the study period, Incremental protocol follows the conventional dose regimen starting pregabaline 75mg bid.
Pregabalin 25mg, 50mgDrug
Also called New regimen
Through the study period, Incremental protocol follows the new dose regimen starting pregabalin 25mg, 50mg
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin 75mg bid | Active comparator | The patients who were prescribed according to the conventional flexible dose regimen Receives: Drug: Pregabalin 75mg bid |
| pregabalin 25mg,50mg | Experimental | The patients who were prescribed according to the new flexible dose regimen. Receives: Drug: Pregabalin 25mg, 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
discontinuation of medication
the portion of patients discontinuing medication
Measured: After 7 weeks of prescription
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start10 Oct 2018
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Why it stopped: Participants couldn't be enrolled due to complain of frequent visit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, NeuropathicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoung-Ho Ryu, MD, Kangbuk Samsung Hospital
- Investigators
- Sung Hyun Lee, MD, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691038
- Sponsor's protocol ID
- 2018-08-013
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Flexible Dose Regimen of Pregabalin and New Flexible Dose Regimen of Pregabalin Using Low Dose: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03691038
- Acronym / sponsor ID
- 2018-08-013
- Conditions
- Pain, Neuropathic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participants couldn't be enrolled due to complain of frequent visit.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 1 Oct 2018 (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.
The purpose of this study is to propose a new flexible dose regimen starting from 75mg using the low dose pregabalin 25 mg and 50 mg comparing the side effect and compliance with the conventional flexible dose regimen staring from 150mg using the pregabalin 75mg.
Detailed description
Pregabalin has been shown to be effective as a first-line medication for neuropathic pain but it appears to have several side effects such as dizziness, drowsiness, and edema, which lowers compliance with medications. A way to reduce side effects is the flexible dose regimen, which reaches the target dose to treat the drug. The proposed flexible dose regimen is a regimen that begins with twice the prevalence of 75 mg. However, dizziness is the most common side effect up to 20% in conventional flexible dose regimen. Therefore, the aim of this study was to propose a new flexible regimen starting at a dose less than the existing dose and to compare compliance with pregabaline according to both methods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin 75mg bid | Active comparator | Drug: Pregabalin 75mg bidThe patients who were prescribed according to the conventional flexible dose regimen |
| pregabalin 25mg,50mg | Experimental | Drug: Pregabalin 25mg, 50mgThe patients who were prescribed according to the new flexible dose regimen. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain score NRS ≥3 Patients complaining of neuropathic pain (except neuropathic pain due to chemotherapy)
- Adult patients aged 19 to 85 years
- Patients who pre-agreed to the study
Key exclusion criteria (5 listed)
- Patients complaining of severe pain (NRS ≥ 8)
- Creatinine clearance of <30 mL / min, the liver was more than 3 times normal
- Patients complaining of dizziness, patients with definite orthostatic hypotension
- Pregnant or lactating patients
- Patients who previously experienced side effects after administration pregabalin.
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 75mg bidAlso: Conventional regimenThrough the study period, Incremental protocol follows the conventional dose regimen starting pregabaline 75mg bid. | Drug | Pregabalin 75mg bid |
| Pregabalin 25mg, 50mgAlso: New regimenThrough the study period, Incremental protocol follows the new dose regimen starting pregabalin 25mg, 50mg | Drug | pregabalin 25mg,50mg |
Primary outcome
discontinuation of medication
Time frame: After 7 weeks of prescription
the portion of patients discontinuing medication
Results and safety
The study was stopped early (reason given: Participants couldn't be enrolled due to complain of frequent visit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- 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.
Sung Hyun Lee, MD principal investigator
Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin 75mg bid and Pregabalin 25mg, 50mg in people with Pain, Neuropathic, run by Kangbuk Samsung Hospital 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 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: stopped early, as of the sponsor's last update on 4 Sep 2020. 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.
Are results available for this study?
The study was stopped early (reason given: Participants couldn't be enrolled due to complain of frequent visit.). Results are not available in the source record.
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?
discontinuation of medication (time frame: After 7 weeks of prescription). 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 4 Sep 2020.