Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
This randomized, double-blind, placebo controlled prospective study will assess the safety and effectiveness of a single intra-articular injection of Monovisc® in providing symptomatic relief of pain caused by idiopathic osteoarthritis (OA) of the knee as compared to a placebo comparator injection of sterile saline.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monovisc® | Experimental | Injectable Hyaluronic Acid Gel |
|
| Saline | Placebo Comparator | 0.9% Sterile Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monovisc® | Device | Intra-articular injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks | The primary endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved >= a 40% improvement (reduction) in the WOMAC Pain Score and show at least 15 mm improvement (reduction) in the WOMAC Pain Score from baseline through 12 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. The primary endpoint uses the ITT population that has data available for both baseline and 12 week time points. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) | Comparison of the change of the Evaluator Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee affect him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points. |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen Schmitz, MD | Prometrika, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Consultants | Hoover | Alabama | 35216 | United States | ||
| Novara Clinical Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Monovisc® | Injectable Hyaluronic Acid Gel Monovisc®: Intra-articular injection |
| FG001 | Saline | 0.9% Sterile Saline Saline: 0.9% Sterile Saline |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline | Other | 0.9% Sterile Saline |
|
| 12 Weeks |
| Patient Global Assessment Change From Baseline Through Week 12 (ITT) | Comparison of the change of the Patient Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers the question "Considering all the ways the osteoarthritis in your study knee affects you, what is your assessment of how much your study knee is bothering you today?" The Patient Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points. | 12 Weeks |
| Range of Motion Change From Baseline Through Week 12 (ITT) | Comparison of the change of Range of Motion from baseline through Week 12 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 12 week time points. | 12 Weeks |
| WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) | This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. The ITT population includes subjects with data at baseline and 12 Week time points. | 12 Weeks |
| Mesa |
| Arizona |
| 85206 |
| United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| Tuscon Orthopaedic Institute | Tucson | Arizona | 85712 | United States |
| Providence Clinical Research | Burbank | California | 91505 | United States |
| San Diego Arthritis Medical Clinic | San Diego | California | 92108 | United States |
| Summit Clinical Research | Aurora | Colorado | 80013 | United States |
| Boulder Medical Center | Boulder | Colorado | 80304 | United States |
| Colorado Orthopedic Consultants | Englewood | Colorado | 80110 | United States |
| Plancher Orthopaedic and Sports Medicine | Cos Cob | Connecticut | 06807 | United States |
| Community Research Foundation | Miami | Florida | 33155 | United States |
| Tampa Medical Clinic | Tampa | Florida | 33614 | United States |
| Resurgens Orthopedics | Cumming | Georgia | 30041 | United States |
| Intermountain Research Center | Boise | Idaho | 83702 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Illinois Bone & Joint Institute | Morton Grove | Illinois | 60053 | United States |
| Wellborn Clinic | Evansville | Indiana | 47713 | United States |
| David Neustadt PSC | Louisville | Kentucky | 40202 | United States |
| Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| Great Lakes Research Group | Bay City | Michigan | 48706 | United States |
| Western Montana Clinic | Missoula | Montana | 59802 | United States |
| Physician Research Collaboration | Lincoln | Nebraska | 68516 | United States |
| Arthritis Center of Reno | Reno | Nevada | 89502 | United States |
| Arthritis, Rheumatic & Back Disease Associates | Voorhees Township | New Jersey | 08043 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Brian Gunnlaugson, MD | Johnstown | Pennsylvania | 15901 | United States |
| The Arthritis Group | Philadelphia | Pennsylvania | 19152 | United States |
| Clinical Research Center of Reading | West Reading | Pennsylvania | 19611 | United States |
| SCRI | Germantown | Tennessee | 38138 | United States |
| Valley Orthopedic Clinic | Harlingen | Texas | 78550 | United States |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
|
| Intend-to-treat ITT |
|
| COMPLETED | Completed through 26 weeks follow-up |
|
| NOT COMPLETED |
|
|
Intent to Treat Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Monovisc® | Injectable Hyaluronic Acid Gel Monovisc®: Intra-articular injection |
| BG001 | Saline | 0.9% Sterile Saline Saline: 0.9% Sterile Saline |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks | The primary endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved >= a 40% improvement (reduction) in the WOMAC Pain Score and show at least 15 mm improvement (reduction) in the WOMAC Pain Score from baseline through 12 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. The primary endpoint uses the ITT population that has data available for both baseline and 12 week time points. | Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points. | Posted | Number | Percentage of subjects | 12 Weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) | Comparison of the change of the Evaluator Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee affect him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points. | Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points. | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Assessment Change From Baseline Through Week 12 (ITT) | Comparison of the change of the Patient Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers the question "Considering all the ways the osteoarthritis in your study knee affects you, what is your assessment of how much your study knee is bothering you today?" The Patient Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points. | Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points. | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Range of Motion Change From Baseline Through Week 12 (ITT) | Comparison of the change of Range of Motion from baseline through Week 12 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 12 week time points. | Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points. | Posted | Mean | Standard Deviation | degrees | 12 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) | This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. The ITT population includes subjects with data at baseline and 12 Week time points. | Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points. | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Percentage Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=50% and 20 mm From Baseline Through 26 Weeks | This post-hoc endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved >= a 50% improvement (reduction) in the WOMAC Pain Score and show at least 20 mm improvement (reduction) in the WOMAC Pain Score from baseline through 26 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. Reduction in the WOMAC Pain Score from baseline (e.g. a negative number) indicates improvement in pain. The primary endpoint uses the ITT population that has data available for both baseline and 26 week timepoints. | Intent-To-Treat population was defined as all randomized patients who received the study injection and had at least one post-injection visit; i.e: at least one visit after the Week 0 visit. | Posted | Number | Percentage of Participants | 26 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Evaluator Global Assessment Change From Baseline Through Week 26 (ITT) | Comparison of the change of the Evaluator Global Assessment from baseline through Week 26 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee affect him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a 0 to 100 mm Visual Analog Scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 26 week time points. | Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points. | Posted | Mean | Standard Deviation | units on a scale | 26 Weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Patient Global Assessment Change From Baseline Through Week 26 (ITT) | Comparison of the change of the Patient Global Assessment from baseline through Week 26 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers the question "Considering all the ways the osteoarthritis in your study knee affects you, what is your assessment of how much your study knee is bothering you today?" The Patient Global Assessment is scored on a 0 to 100 mm Visual analog Scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 26 week time points. | Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points. | Posted | Mean | Standard Deviation | units on a scale | 26 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Range of Motion Change From Baseline Through Week 26 (ITT) | Comparison of the change of Range of Motion from baseline through Week 26 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 26 week time points. | Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points. | Posted | Mean | Standard Deviation | degrees | 26 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT) | This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 26 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. The ITT population includes subjects with data at baseline and 26 Week time points. | Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points. | Posted | Mean | Standard Deviation | units on a scale | 26 Weeks |
|
|
26 Weeks
Not provided
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 | Monovisc® | Injectable Hyaluronic Acid Gel Monovisc®: Intra-articular injection | 9 | 184 | 121 | 184 | ||
| EG001 | Saline | 0.9% Sterile Saline Saline: 0.9% Sterile Saline | 5 | 185 | 123 | 185 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Carotid Artery Stenosis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Stomach Discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Back Injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Joint Sprain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Joint Effusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Migrane | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sinus Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Mezger, Exec Director Clinical Affairs | Anika Therapeutics, Inc. | 781.457.9000 | kmezger@anika.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|