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Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

PG201 tablet

Celebrex capsule

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring PG201, Non-inferiority, 100mm pain VAS

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients ≥40 and ≤ 80years of age.
Patients who meet the American College of Rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow:
a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings.
- Age> 50 years.
- Morning stiffness for less than 30 minutes.
- Crepitus during movement of the weight-bearing knee.
Patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.
Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening.
Patients who had a score of 100mm pain VAS ≤80 mm at screening.
Patients who had a score of 100mm pain VAS ≥50 mm at baseline.
Patients should be able and willing to provide the written informed consent.

Exclusion Criteria:

Patients with a history of surgery or arthroscopy of the study joint within the previous 6 months.
Patients with trauma of study joint within the previous 12 months.
Patients with symptomatic hip osteoarthritis, other condition that would interfere with study assessments.
Patients with any other type of arthritis, active malignancies or any active GI, cardiovascular, renal, hepatic, neurologic, or psychiatric disease.
Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
Patients with uncontrollable hypertension.
Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate aminotransferase > 1.5 times the Upper Lange of normal at screening.
Patients with a history of drug or alcohol abuse.

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PG201 tablet

Celecoxib capsule

Arm Description

Outcomes

Primary Outcome Measures

100mm Pain VAS reduction

Secondary Outcome Measures

Pain VAS total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

The change in the quality of life score

The change in the patient self-assessed & investigator-assessed overall symptom scores

The responder index (RI)

Full Information

NCT ID

NCT01576419

First Posted

April 4, 2012

Last Updated

April 10, 2012

Sponsor

PMG Pharm Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01576419

Brief Title

Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients

Official Title

Double Blinded, Randomized, Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PMG Pharm Co., Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study was to to evaluate the efficacy and safety of PG201 in osteoarthritis patients. This clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%. Assuming 20% drop-out rate, the number of subjects required for each treatment group was estimated to be 154, while the total number of subjects required for the study 308. non-inferiority margin: 8mm

Detailed Description

Patients in the PG201 group were prescribed two PG201 tablets per day(BID) and one celecoxib placebo capsule each in the morning and evening per day for 8 weeks. Patients in the celecoxib group were prescribed celecoxib 200 mg (one 200 mg capsule and one celecoxib placebo capsule) and one PG201 placebo tablet each in the morning and evening per day for 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

PG201, Non-inferiority, 100mm pain VAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

309 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PG201 tablet

Arm Type

Experimental

Arm Title

Celecoxib capsule

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

PG201 tablet

Other Intervention Name(s)

botanical drug

Intervention Description

One PG201 tablet and one celecoxib placebo capsule(after breakfast, in 30minutes), One PG201 tablet and one celecoxib placebo capsule(after dinner, in 30minutes)

Intervention Type

Drug

Intervention Name(s)

Celebrex capsule

Other Intervention Name(s)

chemical drug

Intervention Description

One celecoxib capsule and one PG201 placebo tablet(after breakfast, in 30minutes), one celecoxib placebo capsule and one PG201 placebo tablet(after dinner, in 30minutes)

Primary Outcome Measure Information:

Title

100mm Pain VAS reduction

Time Frame

Screening, Day1, Day28

Secondary Outcome Measure Information:

Title

Pain VAS total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame

Screening, Day1, Day28

Title

Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame

Screening, Day1, Day28

Title

The change in the quality of life score

Time Frame

Day1, Day28

Title

The change in the patient self-assessed & investigator-assessed overall symptom scores

Time Frame

Screening, Day1, Day28

Title

The responder index (RI)

Time Frame

screening, Day1, Day28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients ≥40 and ≤ 80years of age. Patients who meet the American College of Rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow: a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings. Age> 50 years. Morning stiffness for less than 30 minutes. Crepitus during movement of the weight-bearing knee. Patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening. Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening. Patients who had a score of 100mm pain VAS ≤80 mm at screening. Patients who had a score of 100mm pain VAS ≥50 mm at baseline. Patients should be able and willing to provide the written informed consent. Exclusion Criteria: Patients with a history of surgery or arthroscopy of the study joint within the previous 6 months. Patients with trauma of study joint within the previous 12 months. Patients with symptomatic hip osteoarthritis, other condition that would interfere with study assessments. Patients with any other type of arthritis, active malignancies or any active GI, cardiovascular, renal, hepatic, neurologic, or psychiatric disease. Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor. Patients with uncontrollable hypertension. Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate aminotransferase > 1.5 times the Upper Lange of normal at screening. Patients with a history of drug or alcohol abuse.

Overall Study Officials: