Trial Outcomes & Findings for SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder (NCT NCT00479687)
NCT ID: NCT00479687
Last Updated: 2021-04-27
Results Overview
Visual Analogue Scale (VAS) for pain on (shoulder) movement with a range of 0 to100; where 0=No pain at all and 100=Pain as bad as it can be. Q: How bad is the pain in your study shoulder with activity or movement? (For example, when putting on a coat, sleeping on your study shoulder side, combing your hair, reaching a high shelf, etc.) Reported is a single Least square mean point estimate over the 7-26 week time interval using the assessments collected at weeks 7, 13, 20, and 26
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
Ph1: weeks 7 - 26
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
Ph1: Supartz (Double Blind)
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
Ph1: Phosphate Buffered Saline (Double Blind)
Phosphate Buffered Saline 3 injections over 2 weeks
Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
|
Ph2: Supartz (Open Label)
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
|---|---|---|---|
|
Ph 1: Blinded, Randomized, Controlled
STARTED
|
150
|
150
|
0
|
|
Ph 1: Blinded, Randomized, Controlled
COMPLETED
|
125
|
131
|
0
|
|
Ph 1: Blinded, Randomized, Controlled
NOT COMPLETED
|
25
|
19
|
0
|
|
Ph 2: Open Label, Single (Supartz) Arm
STARTED
|
0
|
0
|
224
|
|
Ph 2: Open Label, Single (Supartz) Arm
COMPLETED
|
0
|
0
|
215
|
|
Ph 2: Open Label, Single (Supartz) Arm
NOT COMPLETED
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
Ph1: Supartz (Double Blind)
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
Ph1: Phosphate Buffered Saline (Double Blind)
Phosphate Buffered Saline 3 injections over 2 weeks
Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
|
Ph2: Supartz (Open Label)
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
|---|---|---|---|
|
Ph 1: Blinded, Randomized, Controlled
Adverse Event
|
0
|
2
|
0
|
|
Ph 1: Blinded, Randomized, Controlled
Death
|
0
|
1
|
0
|
|
Ph 1: Blinded, Randomized, Controlled
Lost to Follow-up
|
4
|
5
|
0
|
|
Ph 1: Blinded, Randomized, Controlled
Physician Decision
|
2
|
0
|
0
|
|
Ph 1: Blinded, Randomized, Controlled
Withdrawal by Subject
|
19
|
11
|
0
|
|
Ph 2: Open Label, Single (Supartz) Arm
Adverse Event
|
0
|
0
|
4
|
|
Ph 2: Open Label, Single (Supartz) Arm
Withdrawal by Subject
|
0
|
0
|
3
|
|
Ph 2: Open Label, Single (Supartz) Arm
Lost to Follow-up
|
0
|
0
|
1
|
|
Ph 2: Open Label, Single (Supartz) Arm
Death
|
0
|
0
|
1
|
Baseline Characteristics
SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder
Baseline characteristics by cohort
| Measure |
Ph1: Supartz (Double Blind)
n=150 Participants
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
Ph1: Phosphate Buffered Saline (Double Blind)
n=150 Participants
Phosphate Buffered Saline 3 injections over 2 weeks
Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
82 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
143 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
283 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Ph1: weeks 7 - 26Population: Glenohumeral Osteoarthritis (GH-OA) Intention-to-Treat (ITT) population includes all randomized subjects who had no clinical diagnosis of concomitant pathologies in the trial shoulder
Visual Analogue Scale (VAS) for pain on (shoulder) movement with a range of 0 to100; where 0=No pain at all and 100=Pain as bad as it can be. Q: How bad is the pain in your study shoulder with activity or movement? (For example, when putting on a coat, sleeping on your study shoulder side, combing your hair, reaching a high shelf, etc.) Reported is a single Least square mean point estimate over the 7-26 week time interval using the assessments collected at weeks 7, 13, 20, and 26
Outcome measures
| Measure |
Ph1: Supartz (Double Blind)
n=133 Participants
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
Ph1: Phosphate Buffered Saline (Double Blind)
n=130 Participants
Phosphate Buffered Saline 3 injections over 2 weeks
Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
|
|---|---|---|
|
Visual Analogue Scale (VAS: 0-100) for Pain on Movement
|
53.7665 units on a scale
Standard Error 1.7513
|
57.7659 units on a scale
Standard Error 1.7569
|
Adverse Events
Supartz (Double Blind)
Serious events: 11 serious events
Other events: 54 other events
Deaths: 0 deaths
Phosphate Buffered Saline (Double Blind)
Serious events: 5 serious events
Other events: 56 other events
Deaths: 0 deaths
Supartz (Open Label)
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Supartz (Double Blind)
n=150 participants at risk
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
Phosphate Buffered Saline (Double Blind)
n=150 participants at risk
Phosphate Buffered Saline 3 injections over 2 weeks
Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
|
Supartz (Open Label)
n=224 participants at risk
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Cardiac disorders
Arrhythmia
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Injury, poisoning and procedural complications
Bone fragmentation
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.45%
1/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.3%
2/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.67%
1/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.89%
2/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.45%
1/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.45%
1/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.45%
1/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
Other adverse events
| Measure |
Supartz (Double Blind)
n=150 participants at risk
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
Phosphate Buffered Saline (Double Blind)
n=150 participants at risk
Phosphate Buffered Saline 3 injections over 2 weeks
Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
|
Supartz (Open Label)
n=224 participants at risk
SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
8/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
2.0%
3/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
0.00%
0/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
30.7%
46/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
35.3%
53/150 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
9.4%
21/224 • 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place