MedTrace Logo

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

NCT05318521 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-04-14

No results posted yet for this study

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

Interventions

DRUG

Placebo

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

DRUG

Ibuprofen modified release tablet 800 mg

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).

Sponsors & Collaborators

  • Virginia Contract Research Organization Co., Ltd.

    collaborator OTHER

  • Overseas Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Pamela Kane · Palm Beach Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2022-08-31
Completion
2022-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05318521 on ClinicalTrials.gov