Trial Outcomes & Findings for Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee (NCT NCT00450112)

NCT ID: NCT00450112

Last Updated: 2011-08-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 202 participants
• Primary outcome timeframe: 13 weeks
• Results posted on: 2011-08-22

Participant Flow

A total of 202 patients were entered.

Participant milestones

Measure	2Gel-200 Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Overall Study STARTED	125	77
Overall Study Received Injection	125	74
Overall Study Analyzed Participants	122	74
Overall Study COMPLETED	112	71
Overall Study NOT COMPLETED	13	6

Reasons for withdrawal

Measure	2Gel-200 Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Overall Study Other Treatment Required	5	1
Overall Study Withdrawal by Subject	4	1
Overall Study Lost to Follow-up	2	1
Overall Study Others	2	3

Baseline Characteristics

Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee

Baseline characteristics by cohort

Measure	2Gel-200 n=122 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.	Total n=196 Participants Total of all reporting groups
Age Continuous	61.4 years STANDARD_DEVIATION 10.29 • n=5 Participants	61.6 years STANDARD_DEVIATION 10.50 • n=7 Participants	61.4 years STANDARD_DEVIATION 10.35 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	48 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	26 Participants n=7 Participants	74 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants	74 participants n=7 Participants	196 participants n=5 Participants
Body Mass Index (BMI)	28.6 kilograms/meters square STANDARD_DEVIATION 4.14 • n=5 Participants	29.1 kilograms/meters square STANDARD_DEVIATION 4.01 • n=7 Participants	28.8 kilograms/meters square STANDARD_DEVIATION 4.09 • n=5 Participants
WOMAC VAS Pain Subscore	69.4 Scores on a scale STANDARD_DEVIATION 15.82 • n=5 Participants	69.9 Scores on a scale STANDARD_DEVIATION 15.13 • n=7 Participants	69.5 Scores on a scale STANDARD_DEVIATION 15.53 • n=5 Participants
WOMAC VAS Stiffness Subscore	69.7 scores on a scale STANDARD_DEVIATION 18.31 • n=5 Participants	70.7 scores on a scale STANDARD_DEVIATION 18.40 • n=7 Participants	70.1 scores on a scale STANDARD_DEVIATION 18.30 • n=5 Participants
WOMAC VAS Physical Function Subcore	68.0 scores on a scale STANDARD_DEVIATION 17.96 • n=5 Participants	69.9 scores on a scale STANDARD_DEVIATION 16.35 • n=7 Participants	68.7 scores on a scale STANDARD_DEVIATION 17.35 • n=5 Participants
WOMAC VAS Total Score	68.4 scores on a scale STANDARD_DEVIATION 17.07 • n=5 Participants	69.9 scores on a scale STANDARD_DEVIATION 15.79 • n=7 Participants	69.0 scores on a scale STANDARD_DEVIATION 16.58 • n=5 Participants
Subject Global Evaluations	66.1 scores on a scale STANDARD_DEVIATION 21.81 • n=5 Participants	68.2 scores on a scale STANDARD_DEVIATION 18.85 • n=7 Participants	66.9 scores on a scale STANDARD_DEVIATION 20.70 • n=5 Participants
Physician Global Evaluations	60.5 scores on a scale STANDARD_DEVIATION 16.85 • n=5 Participants	62.6 scores on a scale STANDARD_DEVIATION 20.51 • n=7 Participants	61.3 scores on a scale STANDARD_DEVIATION 18.29 • n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	2Gel-200 n=125 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200	68 participants	43 participants

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: ITT population was used for analysis. 3 patients with 2Gel-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. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Outcome measures

Measure	2Gel-200 n=122 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)	32.3 millimeters Standard Deviation 22.68	35.4 millimeters Standard Deviation 22.97

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: ITT population was used for analysis. 3 patients with 2Gel-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. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Outcome measures

Measure	2Gel-200 n=122 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Improvement From Baseline in WOMAC VAS (Stiffness Subscore)	29.0 millimeters Standard Deviation 24.95	34.5 millimeters Standard Deviation 25.27

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: ITT population was used for analysis. 3 patients with 2Gel-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. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Outcome measures

Measure	2Gel-200 n=122 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Improvement From Baseline in WOMAC VAS (Physical Function Subscore)	30.1 millimeters Standard Deviation 22.85	34.4 millimeters Standard Deviation 24.04

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: ITT population was used for analysis. 3 patients with 2Gel-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 all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Outcome measures

Measure	2Gel-200 n=122 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Improvement From Baseline in WOMAC VAS (Total Score)	30.4 millimeters Standard Deviation 22.60	34.6 millimeters Standard Deviation 23.66

SECONDARY outcome

Timeframe: Weeks 13

Population: ITT population was used for analysis. 3 patients with 2Gel-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 improvements 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	2Gel-200 n=122 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response Participants who met strict responders at week 13	58.0 Percentage of Participants	57.7 Percentage of Participants
Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response Participants who met responders at week 13	75.0 Percentage of Participants	77.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: ITT population was used for analysis. 3 patients with 2Gel-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. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Outcome measures

Measure	2Gel-200 n=122 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Improvement From Baseline in Subject Global Evaluations	29.8 millimeters Standard Deviation 30.76	33.4 millimeters Standard Deviation 26.24

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: ITT population was used for analysis. 3 patients with 2Gel-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 physician 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. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Outcome measures

Measure	2Gel-200 n=122 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Improvement From Baseline in Physician Global Evaluations	27.4 millimeters Standard Deviation 25.08	27.4 millimeters Standard Deviation 27.15

SECONDARY outcome

Timeframe: Week 9 to Week 13

Population: ITT population was used for analysis. 3 patients with 2Gel-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	2Gel-200 n=122 Participants Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 Participants Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Acetaminophen Consumption	1677.4 milligrams Standard Deviation 3135.80	1822.5 milligrams Standard Deviation 2768.22

Adverse Events

2Gel-200

Serious events: 3 serious events

Other events: 44 other events

Deaths: 0 deaths

1PBS1Gel-200

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	2Gel-200 n=125 participants at risk Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 participants at risk Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Gastrointestinal disorders Ileus	0.00% 0/125	1.4% 1/74 • Number of events 1
Injury, poisoning and procedural complications Femur fracture	0.80% 1/125 • Number of events 1	0.00% 0/74
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/125	1.4% 1/74 • Number of events 1
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/125	1.4% 1/74 • Number of events 1
Nervous system disorders Transient ischemic attack	0.80% 1/125 • Number of events 1	0.00% 0/74
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.80% 1/125 • Number of events 1	0.00% 0/74

Other adverse events

Measure	2Gel-200 n=125 participants at risk Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.	1PBS1Gel-200 n=74 participants at risk Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
Musculoskeletal and connective tissue disorders Arthralgia	13.6% 17/125 • Number of events 18	10.8% 8/74 • Number of events 8
Musculoskeletal and connective tissue disorders Joint effusion	21.6% 27/125 • Number of events 29	25.7% 19/74 • Number of events 24
Musculoskeletal and connective tissue disorders Joint swelling	20.0% 25/125 • Number of events 28	23.0% 17/74 • Number of events 22

Additional Information

Clinical Development Dept.

Seikagaku Corporation

Phone: 81-3-5220-8950

Email: hiroyuki.hosokawa@seikagaku.co.jp

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, results or similar information without the express of permission of SKK.
• Publication restrictions are in place

Restriction type: OTHER