Low Back PainPhase 4NCT03768466
Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment
A Phase 4 study testing Brand Name: Targin® in people with Low Back Pain, run by Mundipharma Korea Ltd at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by NSAIDs. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Brand Name: Targin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 21 Nov 2018to 17 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Korean patients age ≥ 19 years old
- Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs
- Patients showing average NRS pain score ≥4 over the last 1 week at screening point
- In case of previous opioids medication history, opioids wash-out period > 30 days before enrolment
- Patients who is willing to voluntarily sign informed consent
Who cannot join
- Patients with any history of hypersensitivity to oxycodone, naloxone or related products
- Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center
Seoul, 05505
SMG-SNU Boramae Medical Center
Seoul, 07061
About this study
Official title: An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs
The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by NSAIDs.
- Conditions
- Low Back Pain
- Being tested
- Brand Name: Targin®
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brand Name: Targin®Drug
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
| Study group | Role | What they receive |
|---|---|---|
| Brand Name: Targin® | Experimental | Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral Receives: Drug: Brand Name: Targin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of NRS average score from week 0 to week 8
reduction of pain intensity of week 8 average NRS score
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start21 Nov 2018
- Primary completion20 Feb 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Korea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JaeHyup Lee, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768466
- Sponsor's protocol ID
- OXN18-KR-401
- Status last verified
- Jan 2021
- First submitted
- 20 Nov 2018
- Last updated
- 25 Jan 2021
- 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 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs
- ClinicalTrials.gov ID
- NCT03768466
- Acronym / sponsor ID
- OXN18-KR-401
- Conditions
- Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Mundipharma Korea LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 7 Dec 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 evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by NSAIDs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brand Name: Targin® | Experimental | Drug: Brand Name: Targin®Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Korean patients age ≥ 19 years old
- Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs
- Patients showing average NRS pain score ≥4 over the last 1 week at screening point
- In case of previous opioids medication history, opioids wash-out period > 30 days before enrolment
- Patients who is willing to voluntarily sign informed consent
Key exclusion criteria (3 listed)
- Patients with any history of hypersensitivity to oxycodone, naloxone or related products
- Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause
- Pregnant or lactating women
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 |
|---|---|---|
| Brand Name: Targin®Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral | Drug | Brand Name: Targin® |
Primary outcome
Change of NRS average score from week 0 to week 8
Time frame: week 8
reduction of pain intensity of week 8 average NRS score
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 25 Jan 2021.
- 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.
JaeHyup Lee principal investigator
SMG-SNU Boramae Medical Center
2 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 Brand Name: Targin® in people with Low Back Pain, run by Mundipharma Korea Ltd at 2 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 3 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 of NRS average score from week 0 to week 8 (time frame: week 8). 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 25 Jan 2021.