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The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the treatment of osteoarthritis pain of the knee or hip.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Capsules 35 mg bid or tid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug | 35 mg bid or tid Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events. | Baseline to Week 52/Early Termination |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. |
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 Medical Research, Corporation | Principal Investigator |
| Matthew Barton, MD | Office of Matthew Barton, MD | Principal Investigator |
| David Bouda, MD | Heartland Clinical Research | 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 |
|---|---|---|---|
| 25913498 | Derived | Altman RD, Strand V, Hochberg MC, Gibofsky A, Markenson JA, Hopkins WE, Cryer B, Kivitz A, Nezzer J, Imasogie O, Young CL. Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, open-label, Phase III safety study. Postgrad Med. 2015 Jun;127(5):517-28. doi: 10.1080/00325481.2015.1040716. Epub 2015 Apr 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac 35 mg Capsules | Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to Week 52/Early Termination |
| Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. | Baseline to Week 52/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 | 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 |
| 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 |
| Marvin Tark, MD | Drug Studies America | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population included all subjects who were treated with at least 1 dose of trial drug. Of the 602 subjects who started the study, 601 received at least 1 dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac 35 mg Capsules | Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator. |
| 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/m2 |
| ||||||||||||||||||||||
| Baseline Mental Component Score of the Short Form-36 Questionnaire | The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| Baseline Physical Component Score of the Short Form-36 Questionnaire | The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. | Mean | Standard Deviation | units on a scale |
|
| 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 | Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events. | Posted | Number | participants | Baseline to Week 52/Early Termination |
|
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 52/Early Termination |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 52/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 Capsules | Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator. | 42 | 601 | 191 | 601 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders |
| |||
| Angina unstable | Cardiac disorders |
| |||
| Atrial fibrillation | Cardiac disorders |
| |||
| Coronary artery disease | Cardiac disorders |
| |||
| Coronary artery stenosis | Cardiac disorders |
| |||
| Myocardial infarction | Cardiac disorders |
| |||
| Hyperparathyroidism | Endocrine disorders |
| |||
| Abdominal hernia | Gastrointestinal disorders |
| |||
| Colitis | Gastrointestinal disorders |
| |||
| Diverticular perforation | Gastrointestinal disorders |
| |||
| Gastrointestinal pain | Gastrointestinal disorders |
| |||
| Intestinal strangulation | Gastrointestinal disorders |
| |||
| Pancreatitis | Cardiac disorders |
| |||
| Small intestinal obstruction | Gastrointestinal disorders |
| |||
| Chest pain | General disorders |
| |||
| Bile duct stone | Hepatobiliary disorders |
| |||
| Diverticulitis | Infections and infestations |
| |||
| Lobar pneumonia | Infections and infestations |
| |||
| Pneumonia | Infections and infestations |
| |||
| Pneumonia bacterial | Infections and infestations |
| |||
| Post procedural infection | Infections and infestations |
| |||
| Septic shock | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Dural tear | Injury, poisoning and procedural complications |
| |||
| Seroma | Injury, poisoning and procedural complications |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders |
| |||
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders |
| |||
| Muscle spasms | Musculoskeletal and connective tissue disorders |
| |||
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Amyotrophic lateral sclerosis | Nervous system disorders |
| |||
| Carotid artery stenosis | Nervous system disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Major depression | Psychiatric disorders |
| |||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
| |||
| Cellulitis | Skin and subcutaneous tissue disorders |
| |||
| Finger amputation | Surgical and medical procedures |
| |||
| Carotid artery stenosis | Vascular disorders |
| |||
| Hypotension | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations |
| |||
| Headache | Nervous system disorders |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Nausea | Gastrointestinal disorders |
|
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| 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 |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| Other |
|
| Title | Measurements |
|---|---|
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