RCT, Blinded, 2-Arm Efficacy Study of IP and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee

NCT05318521 | Unknown Phase 3 FDA Drug

• 1 other identifier: OVEIBUA20201225
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Degenerative Arthritis

Keywords

Ibuprofen Modified-Release Tablets; chronic pain related to osteoarthritis of the knee; general pain; fast onset and longer effectiveness

Outcome Measures

Primary Outcomes (1)

• 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)

  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]

  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]

  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]

  at baseline (Day 1) and Day 8, 15, 22, 29, 43, 57 and 85 as sum of scores of all 24 WOMAC questions.

Other Outcomes (4)

• The ≥ 30% and ≥ 50% responder rate of percent improvement

  from baseline to Week 12

• Mean change from baseline

  over 12 weeks of treatment. [Time frame: Baseline up to Week 12]

• Mean change from baseline in IGADS

  at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85.

Study Arms (2)

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.

Drug: Ibuprofen modified release tablet 800 mg

placebo

PLACEBO COMPARATOR

placebo 800mg, twice daily with 12h interval, for 12-week treatment period.

Drug: Placebo

Interventions

Placebo DRUG

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

Also known as: IBUMR

placebo

Ibuprofen modified release tablet 800 mg DRUG

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).

Also known as: IBUMR

Ibuprofen Modified-Release Tablets 800 mg (IBUMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Overseas Pharmaceuticals, Ltd.: lead
• Virginia Contract Research Organization Co., Ltd.: collaborator

Study Sites (1)

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Pamela Kane

  Palm Beach Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

huaihan Cai

CONTACT

+86 183 5261 6957; caihuaihan@overseaspharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: April 8, 2022
• Study Start: December 10, 2021
• Primary Completion: August 1, 2022
• Study Completion: October 19, 2022
• Last Updated: April 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)