Degenerative ArthritisPhase 3NCT05318521
RCT, Blinded, 2-Arm Efficacy Study of IP and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee
A Phase 3 study testing Ibuprofen modified release tablet 800 mg in people with Degenerative Arthritis, run by Overseas Pharmaceuticals, Ltd. at 11 sites in 2 countries.
Trial summary
It is a Phase III efficacy study as the title 'A randomized, double-blind, parallel-arm study comparing the efficacy of investigational product "Ibuprofen Modified-Release Tablets 800 mg" and placebo in patients with chronic pain related to osteoarthritis of the knee.' The primary objective is to determine the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Arthritis
- What is being tested?
- Ibuprofen modified release tablet 800 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 10 Dec 2021to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥18 years of age at the screening visit.
- Patients diagnosed with symptomatic OA of the knee based on the American College of Rheumatology (ACR) clinical criteria and have an American Rheumatology Association (ARA) functional class rating of I, II, or III (1), for ≥ 3 months prior to date of screening; with recent (≤ 6 months) radiographic evidence of tibiofemoral OA: ≥ Grade 2 on the Kellgren \& Lawrence scale. (In cases where both knees are affected, the most painful knee joint is selected as the target knee for study evaluation).
- Patients had been prescribed NSAIDs or acetaminophen to treat their OA-related pain for at least 3 months prior to the screening visit.
- Following discontinuation of analgesic medication (a washout period of at least 5 times the half-life (prior to Day -7), plus a subsequent additional 7 days prior to Baseline visit (Day -7 to Day-1), patients must have a reported pain score of at least 40 mm for WOMAC Pain intensity question: 'walking on a flat surface' at Baseline Visit.
- Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form or legal representative if he/she is under the statutory age of consent as per the local authority.
Who cannot join
- Patients with a history of gastroduodenal perforations and/or obstructions; gastric and/or duodenal surgery; recent (≤ 6 months) active gastrointestinal (GI) ulceration; inflammatory bowel disease; GI bleeding in the past year.
- Patients with a history of congestive heart failure, coronary artery disease, renal artery stenosis or recent (within 1 year) myocardial infarction, angina, stroke, or transient ischemic attack and/or with uncontrolled hypertension.
- Patients with moderate to severe hepatic impairment (alanine aminotransferase [ALT] or aspartate transaminase [AST] concentrations > 2.5 times the upper limit of normal).
- Patients with a medical condition (e.g., a cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine [adrenal hyperplasia], immunologic, dermatologic, neurologic, oncologic, or psychiatric) or a significant laboratory abnormality that, in the Investigator's opinion, would jeopardize the safety of the patient or is likely to confound the study measurements.
- Patients receiving ongoing opioid therapy for their OA-related pain; or requiring ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments known to interfere with pain perception. (Note: 'stabilized' is defined as being used for at least 3 months).
- Patients who have received intra-articular injection of corticosteroids, hyaluronic acid or platelet-rich plasma in the target knee within 6 months prior to the screening visit (within 1 year for long-acting formulations); or have received opioid medication within 14 days prior to the screening visit.
Show all 17Show fewer
- Patients who are unable to be prescribed NSAIDs or are known or suspected to have hypersensitivity to study medication or their excipients.
- Patients who have participated in investigational drug trials and took any investigational therapy within 90 days or a time of 5 half-lives prior to the study dosing.
- Patients currently pregnant, lactating, or planning to pregnant during the trial period. All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods mentioned below, during dosing and for at least 4 weeks after stopping study treatment.
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
- Combination of any two of the following listed methods: (a+b or a+c, or b+c):
- Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- Subjects with underlying medical, mental, psychological, or other inappropriate conditions that would impair treatment compliance, or in the opinion of the Investigator would not permit to participate in the study.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States7 sites
Core Healthcare
Cerritos, California, 90703
Cvillemedresearch
Charlottesville, Virginia, 22911
National Institute of Clinical Research
Garden Grove, California, 92844
Well Pharma Medical Research
Miami, Florida, 33173
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Paragon Rx Clinical, Inc.
Santa Ana, California, 92703
Palm Beach Research Center
West Palm Beach, Florida, 33409
Taiwan4 sites
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
China Medical University Hospital
Taichung, 40447
Taipei Medical University Hospital
Taipei, 11031
Taipei Municipal Wanfang Hospital
Taipei, 11696
About this study
Official title: A Randomized, Double-Blind, Parallel-Arm Study Comparing the Efficacy of Investigational Product "Ibuprofen Modified-Release Tablets 800 mg" and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee
It is a Phase III efficacy study as the title 'A randomized, double-blind, parallel-arm study comparing the efficacy of investigational product "Ibuprofen Modified-Release Tablets 800 mg" and placebo in patients with chronic pain related to osteoarthritis of the knee.' The primary objective is to determine the analgesic efficacy of orally administered IBUMR in patients with osteoarthritis (OA) of the knee.
The Secondary objectives are to compare the treatment effect on patient pain, function and stiffness between IBUMR- and placebo-treated patients as measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC), to compare the treatment effect on Patient Global Assessment on Disease Activity between IBUMR- and placebo-treated patients, to compare the treatment effect on Investigator's Global Assessment on Disease Activity between IBUMR- and placebo-treated patients, to compare the use of analgesic rescue medicine between IBUMR- and placebo-treated patients, to determine the safety profile of IBUMR.
Read the detailed description
The study is a randomized, double-blinded, placebo-controlled, parallel group-study. The duration will be approximately 127 days (4 weeks screening; 12 weeks treatment; 2 weeks follow-up. Currently, Approximately 9 sites in Taiwan and 6 sites in the United States have been selected. Approximately 500 evaluable patients will be enrolled and randomly assigned to receive IBUMR or placebo at a fixed ratio of 1:1. The treatment regimen will be dosing twice a day (BID) for a total of 12 weeks.. The randomized, IP-treated subject with baseline value for primary analysis will be considered evaluable. Considering an estimated randomization failure rate of 10%, approximately 556 eligible patients will be recruited.
For Primary Endpoint, WOMAC Pain will be measured using visual analogue scale (VAS) ranging from 0 mm (no pain) to 100 mm (extreme pain) at baseline week (Day -6 to Day 1) and at Day 8, 15, 22, 29, 43, 57 and Week 12 (Day 79 to Day 85).
For secondary endpoint, WOMAC Physical function will be measured using VAS ranging from 0 mm (no difficulty) to 100 mm (extreme difficulty) at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. WOMAC stiffness will be measured using VAS ranging from 0 mm (no stiffness) to 100 mm (maximum stiffness) at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. WOMAC Total Index will be calculated at baseline (Day 1) and Day 8, 15, 22, 29, 43, 57 and 85 as sum of scores of all 24 WOMAC questions.
For other secondary endpoints, Patients will perform a PGADS via a 0-100 mm VAS, ranging from 0 mm (best ever) to 100 mm (worst ever) with respect to "Considering all the ways your arthritis conditionhas affected you, how do you feel your arthritis is today? " PGADS will be calculated periodically, at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. The degree of the patient's disease status, based on the Investigator's judgment, in terms of pain intensity, joint swelling and tenderness, functional capacity and ability to flex the knee will be assessed by an established IGADS (0-4 point Likert scale), ranging from 0 (very well) to 4 (very poor). IGADS scores will be calculated periodically, at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85.
Safety will also be monitored and evaluated by changes occurring at the baseline and during treatment periods.
Subjects may withdraw from this study due to reasons. A withdrawal occurs when an enrolled patient ceases to participate in the study, regardless of the circumstances, prior to completion of the protocol. The investigators should try their best to complete the evaluation items for the final evaluation visit upon a patient's withdrawal. The reason for a patient withdrawn from the study will be recorded in the case report form (CRF) and in the patient's medical record.
The sample size of this study was based on results from a previous study (Puopolo et al., 2007(2)) which suggested that the least-square mean (95% CI) change in WOMAC pain scores (WOMAC-PS) from baseline is -24.10 (-27.20, -20.99) for treatment group (2400 mg/day; 800 mg TID) and -16.47 (-20.55, -12.40) for placebo group, respectively.
Considering the regimen of our study product (1600 mg; 800 mg BID) and the primary estimand which imputes efficacy data with baseline values for subjects with intercurrent events, we adjusted the treatment effect to -6.005 which is conditional under a 20% reduction in the treatment effect from the study by Puopolo et al. in 2007 (i.e., -7.63 = -24.10 - (-16.47)) and the effect of data imputation, which the proportions of missing data are assumed to be 15% in treatment group and 20% in control group.
A sample size of 250 in each group will have ≥ 85% power to detect a difference in means of -6.005 between treatment and control groups, assuming that the standard deviation for treatment group (t) is 22.879 and the standard deviation for placebo group (p) is 21.463, using a two group Satterthwaite t-test with a 0.050 two-sided significance level.
Analyses on efficacy endpoints will utilize mITT population. A sensitivity analysis using PP population to analyze efficacy endpoints will be conducted if more than 20% of patients are excluded from PP population. Safety evaluation will be performed on mITT population. The conclusion of efficacy (i.e., primary endpoint analysis) of the study will be made according to the results of mITT analysis.
- Conditions
- Degenerative Arthritis
- Being tested
- Placebo, Ibuprofen modified release tablet 800 mg
- Keywords
- Ibuprofen Modified-Release Tablets, chronic pain related to osteoarthritis of the knee, general pain, fast onset and longer effectiveness
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called IBUMR
The 800mg ibuprofen sustained-release tablet is the same as the next generation of ibuprofen sustained-release tablets developed by foreign pharmaceutical companies, but does not contain a placebo that the active ingredient of ibuprofen
Ibuprofen modified release tablet 800 mgDrug
Also called IBUMR
Medication: ibuprofen modified sustained release tablets 800 mg Ibuprofen sustained Release Tablet 800mg is a new generation of ibuprofen developed by overseas pharmaceutical companies. It works fast and lasts for up to 12 hours. The dosing regimen was twice daily, 12 hours apart. Ibuprofen :2-[4-(2-methylpropyl) phenyl] propionic acid, nonselective nonsteroidal anti-inflammatory drug (NSAID).
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen Modified-Release Tablets 800 mg (IBUMR) | Active comparator | Ibuprofen Modified-Release Tablets 800 mg (IBUMR), twice daily with 12h interval, for 12-week treatment period. Receives: Drug: Ibuprofen modified release tablet 800 mg |
| placebo | Placebo comparator | placebo 800mg, twice daily with 12h interval, for 12-week treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the WOMAC visual analogue 3.1 Pain intensity subscale, over 12 weeks of treatment. [Time frame: Baseline week up to Week 12]
WOMAC Pain will be measured using visual analogue scale (VAS) ranging from 0 mm (no pain) to 100 mm (extreme pain)
Measured: at baseline week (Day -6 to Day 1) and at Day 8, 15, 22, 29, 43, 57 and Week 12 (Day 79 to Day 85).
Secondary outcomes (3)
1. Change from baseline in WOMAC Physical function subscale of the knee over 12 weeks of treatment. [Time frame: Baseline up to Week 12]
WOMAC Physical function will be measured using VAS ranging from 0 mm (no difficulty) to 100 mm (extreme difficulty)
Measured: at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85
2. Change from baseline in WOMAC Joint stiffness subscale of the knee over 12 weeks of treatment. [Time frame: Baseline up to Week 12]
WOMAC stiffness will be measured using VAS ranging from 0 mm (no stiffness) to 100 mm (maximum stiffness)
Measured: at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85
3. Change from baseline in WOMAC Total Index over 12 weeks of treatment. [Time frame: Baseline up to Week 12]
WOMAC Total Index will be calculated
Measured: at baseline (Day 1) and Day 8, 15, 22, 29, 43, 57 and 85 as sum of scores of all 24 WOMAC questions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start10 Dec 2021
- Primary completion12 Aug 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies 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
- Model description
- Approximately 500 evaluable patients will be enrolled. The randomized, IP-treated subject with baseline value for primary analysis will be considered evaluable. Considering an estimated randomization failure rate of 10%, approximately 556 eligible patients will be recruited. Eligible patients will be randomly assigned to receive IBUMR or placebo at a fixed ratio of 1:1. The treatment regimen will be dosing twice a day (BID) for a total of 12 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Pamela Kane, Principal investigator, Palm Beach Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318521
- Sponsor's protocol ID
- OVEIBUA20201225
- Status last verified
- Jul 2026
- First submitted
- 20 Dec 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Arm Study Comparing the Efficacy of Investigational Product "Ibuprofen Modified-Release Tablets 800 mg" and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT05318521
- Acronym / sponsor ID
- OVEIBUA20201225
- Conditions
- Degenerative Arthritis
- Keywords
- Ibuprofen Modified-Release Tablets, chronic pain related to osteoarthritis of the knee, general pain, fast onset and longer effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 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.
It is a Phase III efficacy study as the title 'A randomized, double-blind, parallel-arm study comparing the efficacy of investigational product "Ibuprofen Modified-Release Tablets 800 mg" and placebo in patients with chronic pain related to osteoarthritis of the knee.' The primary objective is to determine the analgesic efficacy of orally administered IBUMR in patients with osteoarthritis (OA) of the knee.
The Secondary objectives are to compare the treatment effect on patient pain, function and stiffness between IBUMR- and placebo-treated patients as measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC), to compare the treatment effect on Patient Global Assessment on Disease Activity between IBUMR- and placebo-treated patients, to compare the treatment effect on Investigator's Global Assessment on Disease Activity between IBUMR- and placebo-treated patients, to compare the use of analgesic rescue medicine between IBUMR- and placebo-treated patients, to determine the safety profile of IBUMR.
Detailed description
The study is a randomized, double-blinded, placebo-controlled, parallel group-study. The duration will be approximately 127 days (4 weeks screening; 12 weeks treatment; 2 weeks follow-up. Currently, Approximately 9 sites in Taiwan and 6 sites in the United States have been selected. Approximately 500 evaluable patients will be enrolled and randomly assigned to receive IBUMR or placebo at a fixed ratio of 1:1. The treatment regimen will be dosing twice a day (BID) for a total of 12 weeks.. The randomized, IP-treated subject with baseline value for primary analysis will be considered evaluable. Considering an estimated randomization failure rate of 10%, approximately 556 eligible patients will be recruited.
For Primary Endpoint, WOMAC Pain will be measured using visual analogue scale (VAS) ranging from 0 mm (no pain) to 100 mm (extreme pain) at baseline week (Day -6 to Day 1) and at Day 8, 15, 22, 29, 43, 57 and Week 12 (Day 79 to Day 85).
For secondary endpoint, WOMAC Physical function will be measured using VAS ranging from 0 mm (no difficulty) to 100 mm (extreme difficulty) at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. WOMAC stiffness will be measured using VAS ranging from 0 mm (no stiffness) to 100 mm (maximum stiffness) at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. WOMAC Total Index will be calculated at baseline (Day 1) and Day 8, 15, 22, 29, 43, 57 and 85 as sum of scores of all 24 WOMAC questions.
For other secondary endpoints, Patients will perform a PGADS via a 0-100 mm VAS, ranging from 0 mm (best ever) to 100 mm (worst ever) with respect to "Considering all the ways your arthritis conditionhas affected you, how do you feel your arthritis is today? " PGADS will be calculated periodically, at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. The degree of the patient's disease status, based on the Investigator's judgment, in terms of pain intensity, joint swelling and tenderness, functional capacity and ability to flex the knee will be assessed by an established IGADS (0-4 point Likert scale), ranging from 0 (very well) to 4 (very poor). IGADS scores will be calculated periodically, at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85.
Safety will also be monitored and evaluated by changes occurring at the baseline and during treatment periods.
Subjects may withdraw from this study due to reasons. A withdrawal occurs when an enrolled patient ceases to participate in the study, regardless of the circumstances, prior to completion of the protocol. The investigators should try their best to complete the evaluation items for the final evaluation visit upon a patient's withdrawal. The reason for a patient withdrawn from the study will be recorded in the case report form (CRF) and in the patient's medical record.
The sample size of this study was based on results from a previous study (Puopolo et al., 2007(2)) which suggested that the least-square mean (95% CI) change in WOMAC pain scores (WOMAC-PS) from baseline is -24.10 (-27.20, -20.99) for treatment group (2400 mg/day; 800 mg TID) and -16.47 (-20.55, -12.40) for placebo group, respectively.
Considering the regimen of our study product (1600 mg; 800 mg BID) and the primary estimand which imputes efficacy data with baseline values for subjects with intercurrent events, we adjusted the treatment effect to -6.005 which is conditional under a 20% reduction in the treatment effect from the study by Puopolo et al. in 2007 (i.e., -7.63 = -24.10 - (-16.47)) and the effect of data imputation, which the proportions of missing data are assumed to be 15% in treatment group and 20% in control group.
A sample size of 250 in each group will have ≥ 85% power to detect a difference in means of -6.005 between treatment and control groups, assuming that the standard deviation for treatment group (t) is 22.879 and the standard deviation for placebo group (p) is 21.463, using a two group Satterthwaite t-test with a 0.050 two-sided significance level.
Analyses on efficacy endpoints will utilize mITT population. A sensitivity analysis using PP population to analyze efficacy endpoints will be conducted if more than 20% of patients are excluded from PP population. Safety evaluation will be performed on mITT population. The conclusion of efficacy (i.e., primary endpoint analysis) of the study will be made according to the results of mITT analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Approximately 500 evaluable patients will be enrolled. The randomized, IP-treated subject with baseline value for primary analysis will be considered evaluable. Considering an estimated randomization failure rate of 10%, approximately 556 eligible patients will be recruited. Eligible patients will be randomly assigned to receive IBUMR or placebo at a fixed ratio of 1:1. The treatment regimen will be dosing twice a day (BID) for a total of 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen Modified-Release Tablets 800 mg (IBUMR) | Active comparator | Drug: Ibuprofen modified release tablet 800 mgIbuprofen Modified-Release Tablets 800 mg (IBUMR), twice daily with 12h interval, for 12-week treatment period. |
| placebo | Placebo comparator | Drug: Placeboplacebo 800mg, twice daily with 12h interval, for 12-week treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients ≥18 years of age at the screening visit.
- Patients diagnosed with symptomatic OA of the knee based on the American College of Rheumatology (ACR) clinical criteria and have an American Rheumatology Association (ARA) functional class rating of I, II, or III (1), for ≥ 3 months prior to date of screening; with recent (≤ 6 months) radiographic evidence of tibiofemoral OA: ≥ Grade 2 on the Kellgren \& Lawrence scale. (In cases where both knees are affected, the most painful knee joint is selected as the target knee for study evaluation).
- Patients had been prescribed NSAIDs or acetaminophen to treat their OA-related pain for at least 3 months prior to the screening visit.
- Following discontinuation of analgesic medication (a washout period of at least 5 times the half-life (prior to Day -7), plus a subsequent additional 7 days prior to Baseline visit (Day -7 to Day-1), patients must have a reported pain score of at least 40 mm for WOMAC Pain intensity question: 'walking on a flat surface' at Baseline Visit.
- Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form or legal representative if he/she is under the statutory age of consent as per the local authority.
Key exclusion criteria (17 listed)
- Patients with a history of gastroduodenal perforations and/or obstructions; gastric and/or duodenal surgery; recent (≤ 6 months) active gastrointestinal (GI) ulceration; inflammatory bowel disease; GI bleeding in the past year.
- Patients with a history of congestive heart failure, coronary artery disease, renal artery stenosis or recent (within 1 year) myocardial infarction, angina, stroke, or transient ischemic attack and/or with uncontrolled hypertension.
- Patients with moderate to severe hepatic impairment (alanine aminotransferase [ALT] or aspartate transaminase [AST] concentrations > 2.5 times the upper limit of normal).
- Patients with a medical condition (e.g., a cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine [adrenal hyperplasia], immunologic, dermatologic, neurologic, oncologic, or psychiatric) or a significant laboratory abnormality that, in the Investigator's opinion, would jeopardize the safety of the patient or is likely to confound the study measurements.
- Patients receiving ongoing opioid therapy for their OA-related pain; or requiring ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments known to interfere with pain perception. (Note: 'stabilized' is defined as being used for at least 3 months).
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 |
|---|---|---|
| PlaceboAlso: IBUMRThe 800mg ibuprofen sustained-release tablet is the same as the next generation of ibuprofen sustained-release tablets developed by foreign pharmaceutical companies, but does not contain a placebo that the active ingredient of ibuprofen | Drug | placebo |
| Ibuprofen modified release tablet 800 mgAlso: IBUMRMedication: ibuprofen modified sustained release tablets 800 mg Ibuprofen sustained Release Tablet 800mg is a new generation of ibuprofen developed by overseas pharmaceutical companies. It works fast and lasts for up to 12 hours. The dosing regimen was twice daily, 12 hours apart. Ibuprofen :2-[4-(2-methylpropyl) phenyl] propionic acid, nonselective nonsteroidal anti-inflammatory drug (NSAID). | Drug | Ibuprofen Modified-Release Tablets 800 mg (IBUMR) |
Primary outcome
Change from baseline in the WOMAC visual analogue 3.1 Pain intensity subscale, over 12 weeks of treatment. [Time frame: Baseline week up to Week 12]
Time frame: at baseline week (Day -6 to Day 1) and at Day 8, 15, 22, 29, 43, 57 and Week 12 (Day 79 to Day 85).
WOMAC Pain will be measured using visual analogue scale (VAS) ranging from 0 mm (no pain) to 100 mm (extreme pain)
3 secondary outcomes
1. Change from baseline in WOMAC Physical function subscale of the knee over 12 weeks of treatment. [Time frame: Baseline up to Week 12]
Time frame: at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85
2. Change from baseline in WOMAC Joint stiffness subscale of the knee over 12 weeks of treatment. [Time frame: Baseline up to Week 12]
Time frame: at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85
3. Change from baseline in WOMAC Total Index over 12 weeks of treatment. [Time frame: Baseline up to Week 12]
Time frame: at baseline (Day 1) and Day 8, 15, 22, 29, 43, 57 and 85 as sum of scores of all 24 WOMAC questions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- 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.
Pamela Kane principal investigator
Palm Beach Research Center
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen modified release tablet 800 mg in people with Degenerative Arthritis, run by Overseas Pharmaceuticals, Ltd. at 11 sites in 2 countries.
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 17 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Taiwan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 the WOMAC visual analogue 3.1 Pain intensity subscale, over 12 weeks of treatment. [Time frame: Baseline week up to Week 12] (time frame: at baseline week (Day -6 to Day 1) and at Day 8, 15, 22, 29, 43, 57 and Week 12 (Day 79 to Day 85).). 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 27 Jul 2026.