Acute Low Back PainPhase 3NCT04082975
Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain
A Phase 3 study testing NVP-1203 and NVP-1203-R in people with Acute Low Back Pain, run by NVP Healthcare at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with acute low back pain. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Low Back Pain
- What is being tested?
- NVP-1203 and NVP-1203-R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 421 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2020to 31 May 2021
- 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
- Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
- Subjects who have symptom of acute low back pain
Who cannot join
- Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial
- Inadequate subject for the clinical trial by the investigator's decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active Controlled, Parallel, Multicenter, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain
The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with acute low back pain.
Read the detailed description
This study is a randomized, double-blind, active-controlled, parallel, phase 3 study to evaluate efficacy and safety of NVP-1203 in patients with acute low back pain.
- Conditions
- Acute Low Back Pain
- Being tested
- NVP-1203, NVP-1203-R, NVP-1203 placebo, NVP-1203-R placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-1203Drug
Oral dose for 7 days
NVP-1203-RDrug
Oral dose for 7 days
NVP-1203 placeboDrug
Oral dose for 7 days
NVP-1203-R placeboDrug
Oral dose for 7 days
| Study group | Role | What they receive |
|---|---|---|
| NVP-1203 | Experimental | NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose Receives: Drug: NVP-1203; Drug: NVP-1203-R placebo |
| NVP-1203-R | Active comparator | NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose Receives: Drug: NVP-1203-R; Drug: NVP-1203 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
Pain intensity is assessed by 100 mm Visual Analogue Scale(VAS) (0 mm = no pain and 100 mm = maximum pain) evaluated from baseline to Day 7.
Measured: Baseline and Day 7
Secondary outcomes (4)
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
Pain intensity is assessed by 100 mm Visual Analogue Scale(VAS) (0 mm = no pain and 100 mm = maximum pain) evaluated from baseline to Day 3.
Measured: Baseline and Day 3
Change from baseline in Finger to Floor Distance(FFD)
FFD is measured by the Investigators who will ask the patients to bend forward and try to touch the floor with the fingers. The distance between the finger to the floor is measured in cm.
Measured: Baseline, Day 3 and Day 7
Change from baseline in Oswestry Disability Index(ODI)
The questionnaire consists of 10 items with each item having 6 answers associated to activities of daily living. The ODI score range is 0 to 100% (low score: minimal disability, high score: bed-bound or exaggerating)
Measured: Baseline, Day 3 and Day 7
Change from baseline in Physician's Global Assessment of Response to Therapy(PGART)
Physician's response of change after administration is assessed on 5-point rating scales(very poor, poor, no change, good and very good).
Measured: Baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Jan 2020
- Primary completion24 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seong-Hwan Moon, MD, Principal investigator, Severance HospitalJin Hwan Kim, MD, Principal investigator, Inje UniversityTae Kyun Kim, MD, Principal investigator, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082975
- Sponsor's protocol ID
- NVP-1203_P3
- Status last verified
- Jun 2021
- First submitted
- 4 Sep 2019
- Last updated
- 7 Jun 2021
- Results posted
- 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 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Controlled, Parallel, Multicenter, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT04082975
- Acronym / sponsor ID
- NVP-1203_P3
- Conditions
- Acute Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 10 Sep 2019 (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 and safety NVP-1203 in patients with acute low back pain.
Detailed description
This study is a randomized, double-blind, active-controlled, parallel, phase 3 study to evaluate efficacy and safety of NVP-1203 in patients with acute low back pain.
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 |
|---|---|---|
| NVP-1203 | Experimental | Drug: NVP-1203, Drug: NVP-1203-R placeboNVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose |
| NVP-1203-R | Active comparator | Drug: NVP-1203-R, Drug: NVP-1203 placeboNVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
- Subjects who have symptom of acute low back pain
Key exclusion criteria (2 listed)
- Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial
- Inadequate subject for the clinical trial by the investigator's decision
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 |
|---|---|---|
| NVP-1203Oral dose for 7 days | Drug | NVP-1203 |
| NVP-1203-ROral dose for 7 days | Drug | NVP-1203-R |
| NVP-1203 placeboOral dose for 7 days | Drug | NVP-1203-R |
| NVP-1203-R placeboOral dose for 7 days | Drug | NVP-1203 |
Primary outcome
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
Time frame: Baseline and Day 7
Pain intensity is assessed by 100 mm Visual Analogue Scale(VAS) (0 mm = no pain and 100 mm = maximum pain) evaluated from baseline to Day 7.
4 secondary outcomes
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
Time frame: Baseline and Day 3
Change from baseline in Finger to Floor Distance(FFD)
Time frame: Baseline, Day 3 and Day 7
Change from baseline in Oswestry Disability Index(ODI)
Time frame: Baseline, Day 3 and Day 7
Change from baseline in Physician's Global Assessment of Response to Therapy(PGART)
Time frame: Baseline and Day 7
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 7 Jun 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.
Seong-Hwan Moon, MD principal investigator
Severance Hospital
Jin Hwan Kim, MD principal investigator
Inje University
Tae Kyun Kim, MD principal investigator
Wonkwang University Hospital
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 NVP-1203 and NVP-1203-R in people with Acute Low Back Pain, run by NVP Healthcare 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 2 inclusion and 2 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 7 Jun 2021. 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?
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS) (time frame: Baseline and Day 7). 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 7 Jun 2021.