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Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742 inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.
Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo tablet |
|
| 25 mg PG-530742 | Experimental | 25 mg PG-530742 |
|
| 50 mg PG-530742 | Experimental | 50 mg PG-530742 |
|
| 100 mg PG-530742 | Experimental | 100 mg PG-530742 |
|
| 200 mg PG-530742 | Experimental | 200 mg PG-530742 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG-530742 | Drug | One 25 mg PG-530742 tablet, twice daily for for one year |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Beary, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Hospital, Gizella telep | Visegrád | Gizella Telep | 2026 | Hungary | ||
| Petz A. Country Hospital, Department of Rheumatology, Hid utca 2. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17958901 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Tablet | Placebo tablet dosed BID |
| FG001 | 25 mg PG-530742 | 25 mg PG-530742 dosed BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
One placebo tablet, twice daily for for one year |
|
| 50 mg PG-530742 | Drug | One 50 mg PG-530742 tablet, twice daily for for one year |
|
| 100 mg PG-530742 | Drug | 100 mg PG-530742 tablet, twice a day for one year |
|
| 200 mg PG-530742 | Drug | 200 mg PG-530742 tablet, twice a day for one year |
|
| 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 |
| Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42. | Miskolc | 3529 | Hungary |
| 95 Stanwell Road | Ashford | Middlesex | TW15 3EA | United Kingdom |
| Royal National Orthapaedic Hsopital, Brackley Hill | Stanmore | Middlesex | HA 7 4LP | United Kingdom |
| St Thomas Hospital, Lambeth Place Road | London | Se17eh | United Kingdom |
| The Crouch Oak Practice, 45 Station Road, Addlestone | Addlestone | Surrey | KT15 2BH | United Kingdom |
| The Medical Centre, Kingston Avenue | East Horsley | Surrey | KT24 6QT | United Kingdom |
| Bridge House Medical Centre, Scholars Lane | Stratford-upon-Avon | Warwickshire | CV37 6HE | United Kingdom |
| Pound Hill Surgery, 1 Crawley Lane, Pound Hill | Crawley | West Sussex | RH10 7DX | United Kingdom |
| Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak | Birmingham | B29 6JD | United Kingdom |
| Synexus Birmingham Clinical Research Centre, Birmingham Research Park | Edgbaston | B15 2SQ | United Kingdom |
| Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells | Kent | TN 1 2DX | United Kingdom |
| Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road | London | E11 1NR | United Kingdom |
| Dept of Rheumatology Dulwich Hospital, East Dulwich | London | SE22 8PT | United Kingdom |
| Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House | London Bridge | SE1 9RT | United Kingdom |
| Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens | Reading | RG2 7AG | United Kingdom |
| Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road | Tonbridge | TN10 3ET | United Kingdom |
| Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge | Wigan | WN6 9EW | United Kingdom |
| FG002 |
| 50 mg PG-530742 |
50 mg PG-530742 dosed BID |
| FG003 | 100 mg PG-530742 | 100 mg PG-530742 dosed BID |
| FG004 | 200 mg PG-530742 | 200 mg PG-530742 dosed BID |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Tablet | Placebo tablet dosed BID |
| BG001 | 25 mg PG-530742 | 25 mg PG-530742 dosed BID |
| BG002 | 50 mg PG-530742 | 50 mg PG-530742 dosed BID |
| BG003 | 100 mg PG-530742 | 100 mg PG-530742 dosed BID |
| BG004 | 200 mg PG-530742 | 200 mg PG-530742 dosed BID |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis. analysis. | Posted | Least Squares Mean | Standard Error | mm | baseline and 12 months |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | 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) | An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis. | Posted | Least Squares Mean | Standard Error | Scores on a scale | baseline and 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Tablet | Placebo tablet dosed BID | 8 | 77 | 37 | 77 | ||
| EG001 | 25 mg PG-530742 | 25 mg PG-530742 dosed BID | 7 | 80 | 41 | 80 | ||
| EG002 | 50 mg PG-530742 | 50 mg PG-530742 dosed BID | 12 | 79 | 34 | 79 | ||
| EG003 | 100 mg PG-530742 | 100 mg PG-530742 dosed BID | 10 | 80 | 43 | 80 | ||
| EG004 | 200 mg PG-530742 | 200 mg PG-530742 dosed BID | 17 | 79 | 44 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Athralgia | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Pneumonia NOS | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Cardiac failure NOS | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Localised Osteoarthritis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | COSTART | Non-systematic Assessment |
| |
| Anaemia NOS | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
| |
| Atioventricular block NOS | Cardiac disorders | COSTART | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Tachycardia NOS | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Cataract | Eye disorders | COSTART | Non-systematic Assessment |
| |
| Cataract unilateral | Eye disorders | COSTART | Non-systematic Assessment |
| |
| Diverticulitis NOS | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Duodenal erosions | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastric erosions | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Appendicitis perforated | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Fibrosis NOS | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Chest pain | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Pharyngitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Hip fracture | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Tibia fracture | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Tendon rupture | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | COSTART | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | COSTART | Non-systematic Assessment |
| |
| Humerus fracture | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Biopsy lymph gland abnormal | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Hypoglycaemia NOS | Blood and lymphatic system disorders | COSTART | Systematic Assessment |
| |
| Arthritis NOS | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Periostitis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Toe deformities NOS | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Intervertebral disc herniation | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Dupuytren's contracture | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Fibrositis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Pain in extremity | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Spondylosis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
| |
| Breast cancer NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | Non-systematic Assessment |
| |
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | Non-systematic Assessment |
| |
| Ovarian cancer NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | Non-systematic Assessment |
| |
| Cerebrovascular accident | Vascular disorders | COSTART | Non-systematic Assessment |
| |
| Vertegrobasilar insufficiency | Vascular disorders | COSTART | Non-systematic Assessment |
| |
| Dizziness | Ear and labyrinth disorders | COSTART | Non-systematic Assessment |
| |
| Renal failure NOS | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Urethral stricture | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Prostatic hypertrophy | Reproductive system and breast disorders | COSTART | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Haemorrhage NOS | Vascular disorders | COSTART | Non-systematic Assessment |
| |
| Hypertension NOS | Vascular disorders | COSTART | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders (Overall) | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac disorders (Overall) | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ear and labyrinth disorders (Overall) | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eye disorders (Overall) | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal disorders (Overall) | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| General disorders and administration site conditions (Overall) | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infections and infestation (Overall) | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injury, poisoning and procedural complications (Overall) | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Investigations (Overall) | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Metabolism and nutrition disorders (Overall) | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders (Overall) | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (Overall) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nervous system disorders (Overall) | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Psychiatric disorders | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders (Overall) | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Thomas | Procter & Gamble | 513.622.4838 | thomas.pr@pg.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
|
| Asian Oriental |
|
| Black |
|
| Caucasian |
|
| Hispanic |
|
| Asian Indian |
|
| Multi-Racial |
|
| OG003 | 100 mg PG-530742 | 100 mg PG-530742 dosed BID |
| OG004 | 200 mg PG-530742 | 200 mg PG-530742 dosed BID |
|
|