Trial Outcomes & Findings for Gel-200 Versus Placebo in Osteoarthritis of the Knee (NCT NCT00449696)
NCT ID: NCT00449696
Last Updated: 2011-10-07
Results Overview
Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
COMPLETED
PHASE3
379 participants
Baseline and Week 13
2011-10-07
Participant Flow
A total of 598 patients were screened.
Participant milestones
| Measure |
Gel-200
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Overall Study
STARTED
|
251
|
128
|
|
Overall Study
Received Injection
|
249
|
128
|
|
Overall Study
Analyzed Participants
|
247
|
128
|
|
Overall Study
COMPLETED
|
231
|
119
|
|
Overall Study
NOT COMPLETED
|
20
|
9
|
Reasons for withdrawal
| Measure |
Gel-200
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Overall Study
Other Treatment Required
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Others
|
7
|
0
|
Baseline Characteristics
Gel-200 Versus Placebo in Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.9 years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 9.97 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
247 participants
n=5 Participants
|
128 participants
n=7 Participants
|
375 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28.3 kilograms/meters square
STANDARD_DEVIATION 4.14 • n=5 Participants
|
28.7 kilograms/meters square
STANDARD_DEVIATION 3.83 • n=7 Participants
|
28.5 kilograms/meters square
STANDARD_DEVIATION 4.04 • n=5 Participants
|
|
WOMAC VAS Pain Subscore
|
70.7 scores on a scale
STANDARD_DEVIATION 14.42 • n=5 Participants
|
68.0 scores on a scale
STANDARD_DEVIATION 13.05 • n=7 Participants
|
69.8 scores on a scale
STANDARD_DEVIATION 14.01 • n=5 Participants
|
|
WOMAC VAS Stiffness Subscore
|
71.6 scores on a scale
STANDARD_DEVIATION 17.48 • n=5 Participants
|
69.3 scores on a scale
STANDARD_DEVIATION 17.31 • n=7 Participants
|
70.8 scores on a scale
STANDARD_DEVIATION 17.43 • n=5 Participants
|
|
WOMAC VAS Physical Function Subcore
|
68.9 scores on a scale
STANDARD_DEVIATION 17.41 • n=5 Participants
|
67.6 scores on a scale
STANDARD_DEVIATION 15.80 • n=7 Participants
|
68.5 scores on a scale
STANDARD_DEVIATION 16.87 • n=5 Participants
|
|
WOMAC VAS Total Score
|
69.5 scores on a scale
STANDARD_DEVIATION 15.99 • n=5 Participants
|
67.8 scores on a scale
STANDARD_DEVIATION 14.68 • n=7 Participants
|
68.9 scores on a scale
STANDARD_DEVIATION 15.56 • n=5 Participants
|
|
Subject Global Evaluations
|
64.7 scores on a scale
STANDARD_DEVIATION 21.83 • n=5 Participants
|
66.5 scores on a scale
STANDARD_DEVIATION 21.21 • n=7 Participants
|
65.3 scores on a scale
STANDARD_DEVIATION 21.61 • n=5 Participants
|
|
Physician Global Evaluations
|
61.5 scores on a scale
STANDARD_DEVIATION 14.79 • n=5 Participants
|
64.2 scores on a scale
STANDARD_DEVIATION 14.25 • n=7 Participants
|
62.4 scores on a scale
STANDARD_DEVIATION 14.65 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 13Population: ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.
Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Outcome measures
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore
|
27.8 scores on a scale
Standard Deviation 29.26
|
22.6 scores on a scale
Standard Deviation 29.31
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.
Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Outcome measures
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Change From Baseline in WOMAC VAS Stiffness Subscore
|
26.9 scores on a scale
Standard Deviation 30.46
|
22.5 scores on a scale
Standard Deviation 28.66
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.
Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Outcome measures
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Change From Baseline in WOMAC VAS Physical Function Subscore
|
26.2 scores on a scale
Standard Deviation 28.81
|
21.0 scores on a scale
Standard Deviation 28.62
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.
Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Outcome measures
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Change From Baseline in WOMAC VAS Total Score
|
26.6 scores on a scale
Standard Deviation 28.41
|
21.5 scores on a scale
Standard Deviation 28.37
|
SECONDARY outcome
Timeframe: Weeks 6 to 13Population: ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.
Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).
Outcome measures
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response
Participants who met strict responders at Week 13
|
45.9 Percentage
|
38.7 Percentage
|
|
Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response
Participants who met responders at Week 13
|
61.0 Percentage
|
54.6 Percentage
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.
Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10.
Outcome measures
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Change From Baseline in Short Form - 36 (SF-36)
|
4.6 scores
Standard Deviation 9.34
|
5.3 scores
Standard Deviation 9.04
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.
Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Outcome measures
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Change From Baseline in Subject Global Evaluations
|
22.8 scores on a scale
Standard Deviation 33.08
|
22.0 scores on a scale
Standard Deviation 30.58
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule.
Observed physician global evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Outcome measures
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Change From Baseline in Physician Global Evaluations
|
21.3 scores on a scale
Standard Deviation 28.46
|
19.0 scores on a scale
Standard Deviation 26.97
|
SECONDARY outcome
Timeframe: Weeks 9 to 13 (5 weeks)Population: ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.
Weekly mean acetaminophen consumption between weeks 9 and 13.
Outcome measures
| Measure |
Gel-200
n=247 Participants
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 Participants
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Acetaminophen Consumption
|
2007 milligrams
Standard Deviation 3687
|
2599 milligrams
Standard Deviation 3806
|
Adverse Events
Gel-200
PBS Placebo
Serious adverse events
| Measure |
Gel-200
n=249 participants at risk
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 participants at risk
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Eye disorders
Vision blurred
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
1/249 • Number of events 2
|
0.00%
0/128
|
|
Gastrointestinal disorders
Femoral hernia
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Hepatobiliary disorders
Cryptogenic cirrhosis
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Nervous system disorders
Dizziness
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Nervous system disorders
Transient Ischemic attack
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Renal and urinary disorders
Renal failure acute
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Exertional Dyspnea
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.40%
1/249 • Number of events 1
|
0.00%
0/128
|
Other adverse events
| Measure |
Gel-200
n=249 participants at risk
Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
|
PBS Placebo
n=128 participants at risk
Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infections
|
6.4%
16/249 • Number of events 16
|
4.7%
6/128 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
28.1%
70/249 • Number of events 91
|
28.1%
36/128 • Number of events 42
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
23.3%
58/249 • Number of events 69
|
25.8%
33/128 • Number of events 40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.7%
44/249 • Number of events 55
|
11.7%
15/128 • Number of events 22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee SKK has the right to review the disclosures. Investigator shall not make any publication of study data, information, results or similar information without the express of permission of SKK.
- Publication restrictions are in place
Restriction type: OTHER