Trials Sponsors Conditions Drugs Pricing

Conditions

Osteoarthritis, Knee

Keywords

Primary Disease: Knee Primary Osteoarthritis

Outcome Measures

Primary Outcomes (2)

Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment
The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.
baseline and 12 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year
The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)
baseline and 12 months

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

25 mg PG-530742

EXPERIMENTAL

25 mg PG-530742

Drug: PG-530742

50 mg PG-530742

EXPERIMENTAL

50 mg PG-530742

Drug: 50 mg PG-530742

Interventions

PG-530742Drug

One 25 mg PG-530742 tablet, twice daily for for one year

25 mg PG-530742

PlaceboDrug

One placebo tablet, twice daily for for one year

Placebo

Eligibility Criteria

Age40 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

mild to moderate knee osteoarthritis confirmed by a radiographic technique.

You may not qualify if:

Sponsors & Collaborators

Procter and Gamble
Industrylead

Study Sites (23)

Rehabilitation Hospital, Gizella telep

Visegrád, Gizella Telep, 2026, Hungary

Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.

Győr, Hid Utica 2, 9025, Hungary

National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40

Budapest, 1027, Hungary

National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40

Budapest, 1027, Hungary

National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40

Budapest, 1027, Hungary

Orthopedic Clinic, Karolina ut 17

Budapest, 1113, Hungary

Related Publications (1)

Krzeski P, Buckland-Wright C, Balint G, Cline GA, Stoner K, Lyon R, Beary J, Aronstein WS, Spector TD. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study. Arthritis Res Ther. 2007;9(5):R109. doi: 10.1186/ar2315.
PMID: 17958901DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title: Peter Thomas
Organization: Procter & Gamble

Study Officials

John Beary, MD
Procter and Gamble
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

395 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 16, 2002

First Posted

July 17, 2002

Study Start

July 2002

Date type not reported

This date has not been verified as actual or estimated.

Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (5)

Placebo

25 mg PG-530742

50 mg PG-530742

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (23)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

100 mg PG-530742

200 mg PG-530742

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (5)

Placebo

25 mg PG-530742

50 mg PG-530742

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (23)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

100 mg PG-530742

200 mg PG-530742

Source record

Locations