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| ID | Type | Description | Link |
|---|---|---|---|
| 057 | |||
| 2007_649 |
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The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ibuprofen |
|
| 2 | Placebo Comparator | Placebo 1 |
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| 3 | Placebo Comparator | Placebo 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibuprofen | Drug | Patients will receive 800 mg ibuprofen in one of the three treatment periods. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks | Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk. Change from baseline was average of post-dose PIs minus average of pre-dose PI. | All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20175977 | Result | Peeva E, Beals CR, Bolognese JA, Kivitz AJ, Taber L, Harman A, Smugar SS, Moskowitz RW. A walking model to assess the onset of analgesia in osteoarthritis knee pain. Osteoarthritis Cartilage. 2010 May;18(5):646-53. doi: 10.1016/j.joca.2009.12.008. Epub 2010 Feb 6. |
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This study is a single dose, multi-center, randomized, placebo controlled, cross-over study using the Walking Model of Osteoarthritis (OA) knee pain. The efficacy and tolerability of a single dose of Ibuprofen 800 mg in the setting of standardized walks will be compared with placebo.
First Patient Entered 16 Mar 2007
Multicenter, 3 sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-Placebo-Ibuprofen | First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg |
| FG001 | Placebo-Ibuprofen-Placebo | First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo |
| FG002 | Ibuprofen-Placebo-Placebo | Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Period |
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| Second Treatment Period |
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| Third Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks | Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk. Change from baseline was average of post-dose PIs minus average of pre-dose PI. | This is a crossover study. Total number of participants was 33; every participant had one ibuprofen period and two placebo periods. | Posted | Least Squares Mean | Standard Deviation | Units on a Scale | All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval) |
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From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
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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-Placebo-Ibuprofen | First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Ductal Cancer Infiltrating | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment | Breast cancer diagnosed prior to randomization, and considered unrelated to study drug therapy by the investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Patients will receive placebo to ibuprofen in two of the three treatment periods. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo 1 | First Single dose placebo |
| OG002 | Placebo 2 | Second Single dose placebo |
|
|
|
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | Placebo-Ibuprofen-Placebo | First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo | 0 | 11 | 3 | 11 |
| EG002 | Ibuprofen-Placebo-Placebo | Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo | 1 | 11 | 3 | 11 |
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| Boil on Buttock | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Cold Symptoms | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Urinary Track Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Hip Discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Pain in Joint involving hand | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Pain in Hip | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Tibia Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Unilateral Leg Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Sinus Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Tingling | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012216 |
| Rheumatic Diseases |