Degenerative Arthritis Clinical Trial
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | October 19, 2022 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male and female patients =18 years of age at the screening visit. 2. 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). 3. Patients had been prescribed NSAIDs or acetaminophen to treat their OA-related pain for at least 3 months prior to the screening visit. 4. 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. 5. 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. Exclusion Criteria: 1. 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. 2. 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. 3. Patients with moderate to severe hepatic impairment (alanine aminotransferase [ALT] or aspartate transaminase [AST] concentrations > 2.5 times the upper limit of normal). 4. 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. 5. 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). 6. 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. 7. Patients who are unable to be prescribed NSAIDs or are known or suspected to have hypersensitivity to study medication or their excipients. 8. 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. 9. 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): 1. 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. 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS). 3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. 10. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Palm Beach Research Center | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Overseas Pharmaceuticals, Ltd. | Virginia Contract Research Organization Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The = 30% and = 50% responder rate of percent improvement | use the WOMAC Pain intensity subscale | from baseline to Week 12 | |
Other | Mean change from baseline | use Patient Global Assessment of Disease Status (PGADS) .a PGADS via a 0-100 mm VAS, ranging from 0 mm (best ever) to 100 mm (worst ever) | over 12 weeks of treatment. [Time frame: Baseline up to Week 12] | |
Other | Mean change from baseline in IGADS | 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. | at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. | |
Other | Mean use of rescue medication (daily average number of tablets) | record and statistically analyse the mean use of rescue medication (daily average number of tablets) for each arm | [Time frame: Baseline up to Week 12] | |
Primary | 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 | 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) | at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85 | |
Secondary | 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) | at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85 | |
Secondary | 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 | at baseline (Day 1) and Day 8, 15, 22, 29, 43, 57 and 85 as sum of scores of all 24 WOMAC questions. |
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