Trial Outcomes & Findings for Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee (NCT NCT00653432)
NCT ID: NCT00653432
Last Updated: 2023-07-11
Results Overview
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.
COMPLETED
NA
369 participants
12 Weeks
2023-07-11
Participant Flow
Participant milestones
| Measure |
Monovisc®
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
185
|
|
Overall Study
Intend-to-treat ITT
|
181
|
184
|
|
Overall Study
COMPLETED
|
162
|
169
|
|
Overall Study
NOT COMPLETED
|
22
|
16
|
Reasons for withdrawal
| Measure |
Monovisc®
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
|
Overall Study
Use/Need of Con Therapy
|
2
|
1
|
|
Overall Study
Other - Reason Not Provided
|
5
|
3
|
Baseline Characteristics
Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Monovisc®
n=181 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=184 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
317 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
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.
Outcome measures
| Measure |
Monovisc®
n=173 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=173 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks
|
62.57 Percentage of subjects
|
56.14 Percentage of subjects
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
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.
Outcome measures
| Measure |
Monovisc®
n=171 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=171 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)
Change from Baseline in Evaluator Global 12 weeks
|
-28.6 units on a scale
Standard Deviation 26.4
|
-26.4 units on a scale
Standard Deviation 26.4
|
|
Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)
Baseline Evaluator Global
|
59.1 units on a scale
Standard Deviation 15.5
|
58.9 units on a scale
Standard Deviation 14.6
|
|
Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)
12 Week Evaluator Global
|
30.4 units on a scale
Standard Deviation 23.5
|
32.1 units on a scale
Standard Deviation 23.2
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
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.
Outcome measures
| Measure |
Monovisc®
n=171 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=171 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Patient Global Assessment Change From Baseline Through Week 12 (ITT)
Change from Baseline in Patient Global 12 weeks
|
-28.8 units on a scale
Standard Deviation 30.8
|
-28.9 units on a scale
Standard Deviation 27.7
|
|
Patient Global Assessment Change From Baseline Through Week 12 (ITT)
Baseline Patient Global
|
62.9 units on a scale
Standard Deviation 17.5
|
61.6 units on a scale
Standard Deviation 16.7
|
|
Patient Global Assessment Change From Baseline Through Week 12 (ITT)
12 Week Patient Global
|
33.7 units on a scale
Standard Deviation 25.0
|
33.2 units on a scale
Standard Deviation 24.9
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
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.
Outcome measures
| Measure |
Monovisc®
n=171 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=171 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Range of Motion Change From Baseline Through Week 12 (ITT)
Change from Baseline in Range of Motion 12 weeks
|
1.5 degrees
Standard Deviation 14.9
|
4.6 degrees
Standard Deviation 14.4
|
|
Range of Motion Change From Baseline Through Week 12 (ITT)
Baseline Range of Motion
|
116.3 degrees
Standard Deviation 16.4
|
114.5 degrees
Standard Deviation 16.0
|
|
Range of Motion Change From Baseline Through Week 12 (ITT)
12 Week Range of Motion
|
117.8 degrees
Standard Deviation 14.4
|
119.3 degrees
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.
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.
Outcome measures
| Measure |
Monovisc®
n=171 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=171 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)
Baseline WOMAC Function
|
55.8 units on a scale
Standard Deviation 15.9
|
54.1 units on a scale
Standard Deviation 17.3
|
|
WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)
Change from Baseline in WOMAC Function 12 weeks
|
-24.1 units on a scale
Standard Deviation 26.1
|
-22.3 units on a scale
Standard Deviation 25.4
|
|
WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)
12 Week WOMAC Function
|
31.6 units on a scale
Standard Deviation 26.2
|
31.7 units on a scale
Standard Deviation 25.3
|
POST_HOC outcome
Timeframe: 26 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Monovisc®
n=171 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=171 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Percentage Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=50% and 20 mm From Baseline Through 26 Weeks
|
44.38 Percentage of Participants
|
34.12 Percentage of Participants
|
POST_HOC outcome
Timeframe: 26 WeeksPopulation: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.
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.
Outcome measures
| Measure |
Monovisc®
n=162 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=168 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Evaluator Global Assessment Change From Baseline Through Week 26 (ITT)
Change from Baseline in Evaluator Global 26 weeks
|
-27.9 units on a scale
Standard Deviation 24.2
|
-27.5 units on a scale
Standard Deviation 27.5
|
|
Evaluator Global Assessment Change From Baseline Through Week 26 (ITT)
Baseline Evaluator Global
|
59.1 units on a scale
Standard Deviation 15.5
|
58.9 units on a scale
Standard Deviation 14.6
|
|
Evaluator Global Assessment Change From Baseline Through Week 26 (ITT)
26 Week Evaluator Global
|
31.9 units on a scale
Standard Deviation 22.0
|
30.9 units on a scale
Standard Deviation 22.9
|
POST_HOC outcome
Timeframe: 26 WeeksPopulation: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.
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.
Outcome measures
| Measure |
Monovisc®
n=162 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=168 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Patient Global Assessment Change From Baseline Through Week 26 (ITT)
Change from Baseline in Patient Global 26 weeks
|
-28.5 units on a scale
Standard Deviation 27.9
|
-28.6 units on a scale
Standard Deviation 27.2
|
|
Patient Global Assessment Change From Baseline Through Week 26 (ITT)
Baseline Patient Global
|
62.9 units on a scale
Standard Deviation 17.5
|
61.6 units on a scale
Standard Deviation 16.7
|
|
Patient Global Assessment Change From Baseline Through Week 26 (ITT)
26 Week Patient Global
|
33.7 units on a scale
Standard Deviation 26.0
|
33.4 units on a scale
Standard Deviation 26.2
|
POST_HOC outcome
Timeframe: 26 WeeksPopulation: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.
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.
Outcome measures
| Measure |
Monovisc®
n=162 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=168 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Range of Motion Change From Baseline Through Week 26 (ITT)
Change from Baseline in Range of Motion 26 Weeks
|
1.0 degrees
Standard Deviation 14.9
|
4.2 degrees
Standard Deviation 14.6
|
|
Range of Motion Change From Baseline Through Week 26 (ITT)
Baseline Range of Motion
|
116.3 degrees
Standard Deviation 16.4
|
114.5 degrees
Standard Deviation 16.0
|
|
Range of Motion Change From Baseline Through Week 26 (ITT)
26 Week Range of Motion
|
117.2 degrees
Standard Deviation 13.9
|
118.8 degrees
Standard Deviation 14.2
|
POST_HOC outcome
Timeframe: 26 WeeksPopulation: Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.
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.
Outcome measures
| Measure |
Monovisc®
n=162 Participants
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=168 Participants
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT)
26 Week WOMAC Function
|
32.5 units on a scale
Standard Deviation 24.8
|
33.1 units on a scale
Standard Deviation 25.2
|
|
WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT)
Change from Baseline in WOMAC Function 26 weeks
|
-23.3 units on a scale
Standard Deviation 26.0
|
-21.4 units on a scale
Standard Deviation 24.8
|
|
WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT)
Baseline WOMAC Function
|
55.8 units on a scale
Standard Deviation 15.9
|
54.1 units on a scale
Standard Deviation 17.3
|
Adverse Events
Monovisc®
Saline
Serious adverse events
| Measure |
Monovisc®
n=184 participants at risk
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=185 participants at risk
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Cardiac disorders
Angina Unstable
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
|
General disorders
Chest Pain
|
0.00%
0/184 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
|
Infections and infestations
Bronchitis
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/184 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/184 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
|
Reproductive system and breast disorders
Rectocele
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/184 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
Other adverse events
| Measure |
Monovisc®
n=184 participants at risk
Injectable Hyaluronic Acid Gel
Monovisc®: Intra-articular injection
|
Saline
n=185 participants at risk
0.9% Sterile Saline
Saline: 0.9% Sterile Saline
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/184 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Infections and infestations
Bronchitis
|
2.2%
4/184 • Number of events 5 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Infections and infestations
Cystitis
|
1.6%
3/184 • Number of events 3 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Infections and infestations
Gastroenteritis Viral
|
1.6%
3/184 • Number of events 3 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Infections and infestations
Influenza
|
2.7%
5/184 • Number of events 5 • 26 Weeks
|
4.3%
8/185 • Number of events 8 • 26 Weeks
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
9/184 • Number of events 9 • 26 Weeks
|
5.9%
11/185 • Number of events 11 • 26 Weeks
|
|
Infections and infestations
Sinusitis
|
3.3%
6/184 • Number of events 7 • 26 Weeks
|
2.7%
5/185 • Number of events 5 • 26 Weeks
|
|
Infections and infestations
Tooth Abscess
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/184 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.0%
11/184 • Number of events 14 • 26 Weeks
|
7.6%
14/185 • Number of events 16 • 26 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
2.7%
5/185 • Number of events 6 • 26 Weeks
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
1.6%
3/185 • Number of events 3 • 26 Weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/184 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Gastrointestinal disorders
Stomach Discomfort
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
|
Gastrointestinal disorders
Toothache
|
2.7%
5/184 • Number of events 6 • 26 Weeks
|
2.2%
4/185 • Number of events 7 • 26 Weeks
|
|
General disorders
Influenza Like Illness
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
|
General disorders
Injection Site Pain
|
1.6%
3/184 • Number of events 3 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
|
General disorders
Malaise
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
1.6%
3/185 • Number of events 3 • 26 Weeks
|
|
General disorders
Oedema Peripheral
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
General disorders
Pain
|
1.6%
3/184 • Number of events 4 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
General disorders
Pyrexia
|
0.00%
0/184 • 26 Weeks
|
1.6%
3/185 • Number of events 3 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
3.3%
6/184 • Number of events 9 • 26 Weeks
|
4.9%
9/185 • Number of events 11 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.6%
3/184 • Number of events 3 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
4.3%
8/185 • Number of events 8 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
2.2%
4/184 • Number of events 4 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
1.6%
3/185 • Number of events 3 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.8%
31/184 • Number of events 59 • 26 Weeks
|
14.6%
27/185 • Number of events 44 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.7%
16/184 • Number of events 26 • 26 Weeks
|
8.6%
16/185 • Number of events 25 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
2.7%
5/184 • Number of events 6 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.54%
1/185 • Number of events 2 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
2.2%
4/185 • Number of events 5 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.2%
4/184 • Number of events 4 • 26 Weeks
|
1.1%
2/185 • Number of events 3 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
4.9%
9/184 • Number of events 20 • 26 Weeks
|
3.8%
7/185 • Number of events 7 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/184 • 26 Weeks
|
1.6%
3/185 • Number of events 3 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
1.1%
2/185 • Number of events 3 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.54%
1/184 • Number of events 2 • 26 Weeks
|
2.7%
5/185 • Number of events 5 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
2/184 • Number of events 3 • 26 Weeks
|
1.6%
3/185 • Number of events 3 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.2%
15/184 • Number of events 24 • 26 Weeks
|
7.0%
13/185 • Number of events 14 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.6%
3/184 • Number of events 3 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Nervous system disorders
Headache
|
13.0%
24/184 • Number of events 39 • 26 Weeks
|
15.1%
28/185 • Number of events 56 • 26 Weeks
|
|
Nervous system disorders
Hypoaesthesia
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Nervous system disorders
Migrane
|
1.6%
3/184 • Number of events 3 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Nervous system disorders
Sciatica
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
2.2%
4/185 • Number of events 4 • 26 Weeks
|
|
Nervous system disorders
Sinus Headache
|
2.2%
4/184 • Number of events 5 • 26 Weeks
|
4.9%
9/185 • Number of events 14 • 26 Weeks
|
|
Psychiatric disorders
Depression
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Psychiatric disorders
Insomnia
|
1.6%
3/184 • Number of events 3 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.1%
2/184 • Number of events 3 • 26 Weeks
|
0.54%
1/185 • Number of events 2 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
2.2%
4/184 • Number of events 4 • 26 Weeks
|
2.2%
4/185 • Number of events 4 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.54%
1/184 • Number of events 1 • 26 Weeks
|
1.1%
2/185 • Number of events 2 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.00%
0/185 • 26 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
0.54%
1/185 • Number of events 1 • 26 Weeks
|
|
Vascular disorders
Hypertension
|
1.1%
2/184 • Number of events 2 • 26 Weeks
|
1.6%
3/185 • Number of events 3 • 26 Weeks
|
Additional Information
Kara Mezger, Exec Director Clinical Affairs
Anika Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place