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The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Capsules 35 mg bid | Experimental |
| |
| Diclofenac Capsules 35 mg tid | Experimental |
| |
| Placebo Capsule | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug | 35 mg bid Capsules |
| |
| Diclofenac |
| 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 |
|---|---|---|
| John M Agaiby, MD | Clinical Investigation Specialists, Inc | 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 |
| Venkata Challa, MD | Peters Medical Research | Principal Investigator |
| John Champlin, MD | Med Center | Principal Investigator |
| Francisco Chevres, MD | Pinnacle Trials, Inc | Principal Investigator |
| Melanie Christina, MD | Clinical Investigations of Texas, LLC | Principal Investigator |
| James R Clark, MD | Charlottesville Medical Research Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Research Group - Phoenix | Phoenix | Arizona | 85027 | United States | ||
| Lynn Institute of the Ozarks |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25050589 | Derived | Gibofsky A, Hochberg MC, Jaros MJ, Young CL. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014 Sep;30(9):1883-93. doi: 10.1185/03007995.2014.946123. Epub 2014 Aug 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac 35 mg Two Times Daily | Diclofenac (two times daily): Capsules |
| FG001 | Diclofenac 35 mg Three Times Daily | Diclofenac (three times daily): Capsules |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
35 mg tid Capsules |
|
| Placebo | Drug | Capsules |
|
| 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 average of the WOMAC pain 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 Pain, Stiffness, and Function Measured Using the Total (Composite) 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 (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) 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 Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale. | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Pain Imaginable". The VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline. | Baseline to Week 12/Early Termination |
| Stephen Daniels, DO |
| Premier Research Group - Austin |
| Principal Investigator |
| Richard R Eckert, MD | Hypothetest, LLC | Principal Investigator |
| Brandon Essink, MD | Meridian Clinical Research | Principal Investigator |
| Richard M Glover, MD | Heartland Research Associates, LLC | Principal Investigator |
| Kent S Hoffman, DO | Alliance Clinical Research | Principal Investigator |
| Curtis S Horn, MD | Quality Research Inc | Principal Investigator |
| Raymond E Jackson, MD | Quest Research Institute | Principal Investigator |
| Jeffry Jacqmein, MD | Jacksonville Center For Clinical Research | Principal Investigator |
| Enrico Jones, MD | Triad Clinical Research | Principal Investigator |
| Alan Kivitz, MD | Altoona Center for Clinical Research | Principal Investigator |
| Kevin Kuettel, MD | ACRI-Phase I, LLC | Principal Investigator |
| Gregory F Lakin, DO | Professional Research Network of Kansas, LLC | Principal Investigator |
| Theresia Lee, MD | Progressive Clinical Research | Principal Investigator |
| Sathish Modugu, MD | Drug Trials America | Principal Investigator |
| Julie A Mullen, DO | Sterling Research Group, Ltd | Principal Investigator |
| Kashyap Patel, MD | Peninsula Research, Inc | Principal Investigator |
| Kyle Patrick, DO | Premier Research Group - Phoenix | Principal Investigator |
| Antoinette A Pragalos, MD | Community Research | Principal Investigator |
| Larry D Reed, MD, PhD | Healthcare Research | Principal Investigator |
| Eli M Roth, MD | Sterling Research Group, Ltd | Principal Investigator |
| Douglas R Schumacher, MD | Radiant Research, Inc | Principal Investigator |
| Mark Stich, DO | Westside Center for Clinical Research | Principal Investigator |
| Bradley Swenson, MD | Radiant Research, Inc | Principal Investigator |
| Marvin Tark, MD | Drug Studies America | Principal Investigator |
| Gary Tarshis, MD | Expresscare Clinical Research | Principal Investigator |
| Haydn M Thomas, MD | Clinical Trials Technology Inc | Principal Investigator |
| Cindy Tuten, MD | Clinical Study Center of Asheville, LLC | Principal Investigator |
| Larkin T Wadsworth, MD | Sundance Clinical Research, LLC | Principal Investigator |
| Robert J Wagner, MD | Community Research | Principal Investigator |
| Larry S Watkins, MD | Lynn Institute of the Ozarks | Principal Investigator |
| Tamela Zimmerman, MD | Community Research | Principal Investigator |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Acri-Phase I, LLC | Anaheim | California | 92801 | United States |
| Med Center | Carmichael | California | 95608 | United States |
| Expresscare Clinical Research | Colorado Springs | Colorado | 80909 | 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 |
| Alliance Clinical Research | Winter Park | Florida | 32792 | United States |
| Pinnacle Trials, Inc | Atlanta | Georgia | 30329 | United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| Clinical Investigation Specialists, Inc | Gurnee | Illinois | 60031 | 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 |
| Quest Research Institute | Bingham Farms | Michigan | 48025 | United States |
| Healthcare Research | Florissant | Missouri | 63031 | 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 | 89106 | United States |
| Drug Trials America | Hartsdale | New York | 10530 | United States |
| Clinical Study Center of Asheville, LLC | Asheville | North Carolina | 28803 | United States |
| Triad Clinical Research | Greensboro | North Carolina | 27408 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| Sterling Research Group, Ltd | Cincinnati | Ohio | 45219 | United States |
| Community Research | Cincinnati | Ohio | 45227 | United States |
| Community Research | Cincinnati | Ohio | 45245 | United States |
| Sterling Research Group, Ltd | Cincinnati | Ohio | 45246 | United States |
| Radiant Research, Inc | Columbus | Ohio | 43212 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Radiant Research, Inc | Anderson | South Carolina | 29621 | United States |
| Premier Research Group - 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 |
| Progressive Clinical Research | 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 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac 35 mg Two Times Daily | Diclofenac (two times daily): Capsules |
| BG001 | Diclofenac 35 mg Three Times Daily | Diclofenac (three times daily): 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 subjects with osteoarthritis 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 (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 within the past 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". | Mean | Standard Deviation | mm |
| ||||||||||||||
| Baseline Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sc | The pain, stiffness, and physical function in subjects with osteoarthritis were measured at baseline using the total (composite) 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 (composite) WOMAC score was calculated for 100 subjects in the Diclofenac Test Capsules two times daily group, 94 subjects in the Diclofenac Test Capsules three times daily group, and 100 subjects in the placebo group. | Mean | Standard Deviation | mm |
| ||||||||||||||
| Baseline Pain Intensity Visual Analogue Scale Score | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The Baseline Pain Intensity VAS score was calculated for 100 subjects in the Diclofenac Test Capsules two times daily group, 94 subjects in the Diclofenac Test Capsules three times daily group, and 100 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 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 average of 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 (Composite) 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 (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) 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 times specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale. | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Pain Imaginable". The VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline. | Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified. | Posted | Least Squares Mean | Standard Error | mm | Baseline to Week 12/Early Termination |
|
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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 | Diclofenac 35 mg Two Times Daily | Diclofenac Test (two times daily): Capsules | 3 | 104 | 11 | 104 | ||
| EG001 | Diclofenac 35 mg Three Times Daily | Diclofenac Test (three times daily): Capsules | 4 | 98 | 21 | 98 | ||
| EG002 | Placebo | Placebo: Capsule | 2 | 103 | 13 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations |
| |||
| Appendicitis | Infections and infestations |
| |||
| Aspartate aminotransferase increased | Investigations |
| |||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Deep vein thrombosis | Vascular disorders |
| |||
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Non-cardiac chest pain | General disorders |
| |||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
| |||
| Hemiplegic migraine | Nervous system disorders |
| |||
| Syncope | Nervous system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Upper respiratory tract infection | Infections and infestations |
|
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
| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White or Caucasian |
|
| Other |
|
| 0.0795 |
| Difference in Least Squares Mean |
| -6.58 |
| Standard Error of the Mean |
| 3.739 |
| 2-Sided |
| 95 |
| -13.94 |
| 0.78 |
| No |
| Superiority or Other |
Placebo: Capsule |
|
|
|
Placebo: Capsule |
|
|
|
| Placebo |
Placebo: Capsule |
|
|
|
| OG002 | Placebo | Placebo: Capsule |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|