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Nonsteroidal Anti-inflammatory Drug

Ibuprofen Modified-Release Tablets 800 mg (IBUMR) for Osteoarthritis

Phase 3
Waitlist Available
Led By Pamela Kane
Research Sponsored by Overseas Pharmaceuticals, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights

Study Summary

This trial is testing a new form of ibuprofen to see if it's more effective than placebo at treating osteoarthritis pain. The study will compare the effects of the new drug to placebo on pain, function, and stiffness, as well as on overall disease activity.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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]
Secondary outcome measures
1. Change from baseline in WOMAC Physical function subscale of the knee over 12 weeks of treatment. [Time frame: Baseline up to Week 12]
2. Change from baseline in WOMAC Joint stiffness subscale of the knee over 12 weeks of treatment. [Time frame: Baseline up to Week 12]
3. Change from baseline in WOMAC Total Index over 12 weeks of treatment. [Time frame: Baseline up to Week 12]
Other outcome measures
Mean change from baseline
Mean change from baseline in IGADS
Mean use of rescue medication (daily average number of tablets)
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Ibuprofen Modified-Release Tablets 800 mg (IBUMR)Active Control1 Intervention
Ibuprofen Modified-Release Tablets 800 mg (IBUMR), twice daily with 12h interval, for 12-week treatment period.
Group II: placeboPlacebo Group1 Intervention
placebo 800mg, twice daily with 12h interval, for 12-week treatment period.

Find a Location

Who is running the clinical trial?

Virginia Contract Research Organization Co., Ltd.OTHER
7 Previous Clinical Trials
431 Total Patients Enrolled
1 Trials studying Osteoarthritis
18 Patients Enrolled for Osteoarthritis
Overseas Pharmaceuticals, Ltd.Lead Sponsor
7 Previous Clinical Trials
137 Total Patients Enrolled
Pamela KanePrincipal InvestigatorPalm Beach Research Center
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
RCT, Blinded, 2-Arm Efficacy Study of IP and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee
2021. "RCT, Blinded, 2-Arm Efficacy Study of IP and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05318521.
~150 spots leftby Apr 2025
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