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The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam Test Capsules low dose QD | Experimental | Meloxicam Test Capsules low dose QD |
|
| Meloxicam Test Capsules high dose QD | Experimental | Meloxicam Test Capsules high dose QD |
|
| Placebo Capsule QD | Placebo Comparator | Placebo Capsule QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam Test Capsules | Drug |
| ||
| Meloxicam Test Capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline. | Baseline to Week 12/Early Termination |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles P Andrews, MD | Diagnostics Research Group | Principal Investigator |
| Eddie Armas, MD | Well Pharma Medical Research Corporation | Principal Investigator |
| Matthew Barton, MD | Office of Matthew Barton, MD | Principal Investigator |
| David Bouda, MD | Heartland Clinical Research, Inc | Principal Investigator |
| John Champlin, MD | Medical Center | Principal Investigator |
| David Chen, MD | Beacon Clinical Research, LLC | Principal Investigator |
| Melanie Christina, MD | Clinical Investigations of Texas, LLC | Principal Investigator |
| James R Clark, MD | Charlottesville Medical Research Center, LLC | Principal Investigator |
| Stephen Daniels, DO | Premier Research Group - Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Achieve Clinical Research, LLC | Birmingham | Alabama | 35216 | United States | ||
| Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26503347 | Derived | Altman R, Hochberg M, Gibofsky A, Jaros M, Young C. Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week, phase 3 study. Curr Med Res Opin. 2015 Dec;31(12):2331-43. doi: 10.1185/03007995.2015.1112772. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Meloxicam 5 mg Once Daily | Meloxicam 5 mg: Capsules |
| FG001 | Meloxicam 10 mg Once Daily | Meloxicam 10 mg: Capsules |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Placebo Capsules | Drug |
|
| Baseline to Week 2 |
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline. | Baseline to Week 6 |
| Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline. | Baseline to Week 12/Early Termination |
| Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline. | Baseline to Week 2 |
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline. | Baseline to Week 6 |
| Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline. | Baseline to Week 12/Early Termination |
| Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline. | Baseline to Week 12/Early Termination |
| Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline. | Baseline to Week 2 |
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline. | Baseline to Week 6 |
| Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline. | Baseline to Week 12/Early Termination |
| Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline. | Baseline to Week 12/Early Termination |
| Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline. | Baseline to Week 2 |
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline. | Baseline to Week 6 |
| Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline. | Baseline to Week 12/Early Termination |
| Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline. | Baseline to Week 12/Early Termination |
| Richard R Eckert, MD |
| Hypothetest, LLC |
| Principal Investigator |
| Brandon Essink, MD | Meridian Clinical Research | Principal Investigator |
| John Flinchbaugh, DO | Fleming Island Center for Clinical Research | Principal Investigator |
| Neil Fraser, MD | Troy Internal Medicine, PC / Research Department | Principal Investigator |
| Richard M Glover, MD | Heartland Research Associates, LLC | Principal Investigator |
| John M Hill, MD | Avail Clinical Research | Principal Investigator |
| Curtis S Horn, MD | Quality Research Inc | Principal Investigator |
| Jeffry Jacqmein, MD | Jacksonville Center For Clinical Research | Principal Investigator |
| Richard Montgomery, MD | Triad Clinical Research | Principal Investigator |
| Alan Kivitz, MD | Altoona Center for Clinical Research | Principal Investigator |
| James Kopp, MD | Radiant Research, Inc | Principal Investigator |
| Gregory F Lakin, DO | Professional Research Network of Kansas, LLC | Principal Investigator |
| Sathish Modugu, MD | Drug Trials America | Principal Investigator |
| Julie Mullen, DO | Sterling Research Group, Ltd | Principal Investigator |
| Thomas Nussdorfer, MD | Medical Research Associates, Inc | Principal Investigator |
| Naynesh Patel, MD | Wells Institute for Health Awareness | Principal Investigator |
| Kashyap Patel, MD | Peninsula Research, Inc | Principal Investigator |
| Stephen J Poland, MD | Community Research | Principal Investigator |
| Larry D Reed, MD, PhD | Healthcare Research | Principal Investigator |
| Erich Schramm, MD | St. Johns Center for Clinical Research | Principal Investigator |
| Douglas R Schumacher, MD | Radiant Research, Inc | Principal Investigator |
| Louis Stephens, MD | Palmetto Clinical Trial Services, LLC | Principal Investigator |
| Mark Stich, DO | Westside Center for Clinical Research | Principal Investigator |
| Haydn M Thomas, MD | Clinical Trials Technology Inc | Principal Investigator |
| Susann Varano, MD | Clinical Research Consulting | Principal Investigator |
| Larkin T Wadsworth, MD | Sundance Clinical Research, LLC | Principal Investigator |
| Robert J Wagner, MD | Community Research | Principal Investigator |
| Matthew A Wenker, MD | Sterling Research Group, Ltd | Principal Investigator |
| Hayes T Williams, MD, PhD | Achieve Clinical Research, LLC | Principal Investigator |
| James Maynard, MD | Community Research | Principal Investigator |
| Roger Guthrie, MD | Arroyo Medical Group, Inc | Principal Investigator |
| Carmichael |
| California |
| 95608 |
| United States |
| Arroyo Medical Group, Inc | Pismo Beach | California | 93449 | United States |
| Clinical Research Consulting | Milford | Connecticut | 06460 | United States |
| Avail Clinical Research | DeLand | Florida | 32720 | United States |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | United States |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Well Pharma Medical Research Corporation | Miami | Florida | 33143 | United States |
| Peninsula Research, Inc | Ormond Beach | Florida | 32174 | United States |
| St Johns Center for Clinical Research | Ponte Vedra | Florida | 32081 | United States |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | United States |
| Clinical Trials Technology Inc | Prairie Village | Kansas | 66206 | United States |
| Professional Research Network of Kansas, LLC | Wichita | Kansas | 67203 | United States |
| Community Research | Crestview Hills | Kentucky | 41017 | United States |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | United States |
| Medical Research Associates, Inc | Traverse City | Michigan | 49684 | United States |
| Troy Internal Medicine, PC / Research Department | Troy | Michigan | 48098 | United States |
| Healthcare Research | Hazelwood | Missouri | 63042 | United States |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | United States |
| Heartland Clinical Research, Inc | Omaha | Nebraska | 68134 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | United States |
| Office of Matthew Barton, MD | Las Vegas | Nevada | 89144 | United States |
| Drug Trials America | Hartsdale | New York | 10530 | United States |
| Triad Clinical Research | Greensboro | North Carolina | 27408 | United States |
| Sterling Research Group, Ltd | Cincinnati | Ohio | 45219 | United States |
| Community Research | Cincinnati | Ohio | 45227 | United States |
| Sterling Research Group, Ltd | Cincinnati | Ohio | 45246 | United States |
| Community Research - Anderson | Cincinnati | Ohio | 45255 | United States |
| Radiant Research, Inc | Columbus | Ohio | 43212 | United States |
| Wells Institute for Health Awareness | Kettering | Ohio | 45429 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Radiant Research, Inc | Anderson | South Carolina | 29621 | United States |
| Palmetto Clinical Trial Services, LLC | Clinton | South Carolina | 29325 | United States |
| Premier Research - Austin | Austin | Texas | 78705 | United States |
| Clinical Investigations of Texas, LLC | Plano | Texas | 75075 | United States |
| Quality Research Inc | San Antonio | Texas | 78209 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | United States |
| Hypothetest, LLC | Roanoke | Virginia | 24018 | United States |
| FG002 |
| Placebo |
Placebo: Capsule |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects in this population received at least 1 dose of study drug and were analyzed according to treatment received, not treatment randomized. One subject who entered the study in the placebo group withdrew before receiving study drug. One subject who was randomized to meloxicam 5 mg received meloxicam 10 mg and was analyzed in that group
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Meloxicam 5 mg Once Daily | Meloxicam 5 mg: Capsules |
| BG001 | Meloxicam 10 mg Once Daily | Meloxicam 10 mg: Capsules |
| BG002 | Placebo | Placebo: Capsule |
| BG003 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times. | Number | participants |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | The pain in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the mean of the visual analogue scale scores from 5 pain subscale questions, with 0 mm meaning "No Pain" and 100 mm meaning "Worst Possible Pain". The pain subscore was calculated for 139 subjects in the Meloxicam 5 mg group, 130 in the Meloxicam 10 mg group, and 133 in the placebo group. | Mean | Standard Deviation | mm |
| ||||||||||||||
| Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscore | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Worst Possible Functional Limitation". The function subscale score was calculated for 138 subjects in the Meloxicam 5 mg group, 130 in the Meloxicam 10 mg group, and 132 in the placebo group. | Mean | Standard Deviation | mm |
| ||||||||||||||
| Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscore | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions, with 0 mm meaning "No Stiffness" and 100 mm meaning "Worst Possible Stiffness". The stiffness subscale score was calculated for 139 subjects in the Meloxicam 5 mg group, 130 in the Meloxicam 10 mg group, and 132 in the placebo group. | Mean | Standard Deviation | mm |
| ||||||||||||||
| Baseline Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | The pain, stiffness, and physical function in subjects with osteoarthritis were measured at baseline using the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. The total WOMAC score is the average of the mean visual analogue scale scores, with 0 mm meaning "No Limitation" and 100 mm meaning "Extreme Limitation". Baseline total WOMAC score was calculated for 138 subjects in the Meloxicam 5 mg once daily group, 130 subjects in the Meloxicam 10 mg once daily group, and 131 subjects in the placebo group. | Mean | Standard Deviation | mm |
|
| 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 From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
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| Secondary | Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 2 |
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| Secondary | Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 6 |
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| Secondary | Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
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| Secondary | Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 2 |
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| Secondary | Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 6 |
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| Secondary | Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
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| Secondary | Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
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| Secondary | Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 2 |
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| Secondary | Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 6 |
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| Secondary | Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
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| Secondary | Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
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| Secondary | Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 2 |
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| Secondary | Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 6 |
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| Secondary | Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
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| Secondary | Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
|
Not provided
Subjects in this population received at least 1 dose of study drug and were analyzed according to treatment received, not treatment randomized. One subject who entered the study in the placebo group withdrew before receiving study drug. One subject who was randomized to meloxicam 5 mg received meloxicam 10 mg and was analyzed in that group
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meloxicam 5 mg Once Daily | Meloxicam 5 mg: Capsules | 0 | 138 | 14 | 138 | ||
| EG001 | Meloxicam 10 mg Once Daily | Meloxicam 10 mg: Capsules | 0 | 131 | 13 | 131 | ||
| EG002 | Placebo | Placebo: Capsule | 0 | 133 | 10 | 133 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Urinary Tract Infection | Infections and infestations |
| |||
| Abdominal Discomfort | Gastrointestinal disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Solorio, Executive Director of Clinical Operations | Iroko Pharmaceuticals, LLC | 267-546-3150 | dsolorio@iroko.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African-American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| 0.0059 |
| Difference in Least Squares Mean |
| -8.74 |
| Standard Error of the Mean |
| 3.154 |
| 2-Sided |
| 95 |
| -14.94 |
| -2.53 |
| No |
| Superiority or Other |
Placebo: Capsule
|
|
|
Placebo: Capsule
|
|
|
Placebo: Capsule |
|
|
|
| Placebo |
Placebo: Capsule |
|
|
|
| Placebo |
Placebo: Capsule |
|
|
|
| Placebo |
Placebo: Capsule |
|
|
|
| OG002 |
| Placebo |
Placebo: Capsule |
|
|
|
| Placebo |
Placebo: Capsule |
|
|
|
| Placebo |
Placebo: Capsule |
|
|
|
| Placebo |
Placebo: Capsule |
|
|
|
| OG002 |
| Placebo |
Placebo: Capsule |
|
|
|
Placebo: Capsule |
|
|
|
Placebo: Capsule |
|
|
|
| Placebo |
Placebo: Capsule |
|
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|
| Placebo |
Placebo: Capsule |
|
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|