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

This study has been completed.

Study NCT00041756 Information provided by Procter and Gamble

First Received on July 16, 2002. Last Updated on November 7, 2011 History of Changes

Results First Received: August 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Osteoarthritis, Knee
Interventions:	Drug: PG-530742 Drug: Placebo Drug: 50 mg PG-530742 Drug: 100 mg PG-530742 Drug: 200 mg PG-530742

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo Tablet	Placebo tablet dosed BID
25 mg PG-530742	25 mg PG-530742 dosed BID
50 mg PG-530742	50 mg PG-530742 dosed BID
100 mg PG-530742	100 mg PG-530742 dosed BID
200 mg PG-530742	200 mg PG-530742 dosed BID

Participant Flow: Overall Study

	Placebo Tablet	25 mg PG-530742	50 mg PG-530742	100 mg PG-530742	200 mg PG-530742
STARTED	77	80	79	80	79
COMPLETED	69	65	66	64	19
NOT COMPLETED	8	15	13	16	60
Adverse Event	4	10	6	11	34
Protocol Violation	1	1	2	2	1
Withdrawal by Subject	3	3	4	2	3
Lost to Follow-up	0	1	0	1	0
Unable to meet protocol criteria	0	0	1	0	1
Data Monitoring Committee Recommendation	0	0	0	0	21

Baseline Characteristics

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Reporting Groups

	Description
Placebo Tablet	Placebo tablet dosed BID
25 mg PG-530742	25 mg PG-530742 dosed BID
50 mg PG-530742	50 mg PG-530742 dosed BID
100 mg PG-530742	100 mg PG-530742 dosed BID
200 mg PG-530742	200 mg PG-530742 dosed BID

Baseline Measures

	Placebo Tablet	25 mg PG-530742	50 mg PG-530742	100 mg PG-530742	200 mg PG-530742	Total
Number of Participants [units: participants]	77	80	79	80	79	395
Age [units: years] Mean ± Standard Deviation	62.0 ± 0.92	62.4 ± 0.86	62.6 ± 0.92	62.9 ± 0.95	63.1 ± 0.80	62.6 ± 0.40
Gender [units: participants]
Female	54	60	61	57	49	281
Male	23	20	18	23	30	114
Race/Ethnicity, Customized [units: participants]
American Indian	0	0	0	0	0	0
Asian Oriental	0	0	0	0	0	0
Black	0	1	1	1	0	3
Caucasian	77	79	77	75	76	384
Hispanic	0	0	0	0	0	0
Asian Indian	0	0	1	4	3	8
Multi-Racial	0	0	0	0	0	0

Outcome Measures

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1. Primary:

Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment [ Time Frame: baseline and 12 months ]

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2. Primary:

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year [ Time Frame: baseline and 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Peter Thomas
Organization: Procter & Gamble
phone: 513.622.4838
e-mail: thomas.pr@pg.com

No publications provided by Procter and Gamble

Publications automatically indexed to this study:

Krzeski P, Buckland-Wright C, Bálint 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.

Responsible Party:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00041756 History of Changes
Other Study ID Numbers:	2001065
Study First Received:	July 16, 2002
Results First Received:	August 3, 2011
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration