Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Seikagaku Corporation
ClinicalTrials.gov Identifier:
NCT00450112
First received: March 20, 2007
Last updated: July 25, 2011
Last verified: July 2011
Results First Received: April 15, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis of the Knee
Intervention: Device: Gel-200

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 202 patients were entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    2Gel-200     1PBS1Gel-200  
STARTED     125     77  
Received Injection     125     74  
Analyzed Participants     122 [1]   74  
COMPLETED     112     71  
NOT COMPLETED     13     6  
Other Treatment Required                 5                 1  
Withdrawal by Subject                 4                 1  
Lost to Follow-up                 2                 1  
Others                 2                 3  
[1] 3 subjects removed from ITT analyses because of no post treatment data (pre-defined criteria).



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    2Gel-200     1PBS1Gel-200     Total  
Number of Participants  
[units: participants]
  122     74     196  
Age  
[units: years]
Mean ± Standard Deviation
  61.4  ± 10.29     61.6  ± 10.50     61.4  ± 10.35  
Gender  
[units: participants]
     
Female     74     48     122  
Male     48     26     74  
Region of Enrollment  
[units: participants]
     
United States     122     74     196  
Body Mass Index (BMI)  
[units: kilograms/meters square]
Mean ± Standard Deviation
  28.6  ± 4.14     29.1  ± 4.01     28.8  ± 4.09  
WOMAC VAS Pain Subscore [1]
[units: Scores on a scale]
Mean ± Standard Deviation
  69.4  ± 15.82     69.9  ± 15.13     69.5  ± 15.53  
WOMAC VAS Stiffness Subscore [2]
[units: scores on a scale]
Mean ± Standard Deviation
  69.7  ± 18.31     70.7  ± 18.40     70.1  ± 18.30  
WOMAC VAS Physical Function Subcore [3]
[units: scores on a scale]
Mean ± Standard Deviation
  68.0  ± 17.96     69.9  ± 16.35     68.7  ± 17.35  
WOMAC VAS Total Score [4]
[units: scores on a scale]
Mean ± Standard Deviation
  68.4  ± 17.07     69.9  ± 15.79     69.0  ± 16.58  
Subject Global Evaluations [5]
[units: scores on a scale]
Mean ± Standard Deviation
  66.1  ± 21.81     68.2  ± 18.85     66.9  ± 20.70  
Physician Global Evaluations [6]
[units: scores on a scale]
Mean ± Standard Deviation
  60.5  ± 16.85     62.6  ± 20.51     61.3  ± 18.29  
[1] Assessed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) pain subscores on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain.
[2] Assessed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) stiffness subscores on VAS of 100 mm.; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness.
[3] Assessed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) physical function subscores on VAS of 100 mm.; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty.
[4] Mean of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) pain, stiffness and physical function subscores on VAS of 100 mm.; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty.
[5] 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.
[6] 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.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200   [ Time Frame: 13 weeks ]

2.  Secondary:   Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)   [ Time Frame: Baseline and Week 13 ]

3.  Secondary:   Improvement From Baseline in WOMAC VAS (Stiffness Subscore)   [ Time Frame: Baseline and Week 13 ]

4.  Secondary:   Improvement From Baseline in WOMAC VAS (Physical Function Subscore)   [ Time Frame: Baseline and Week 13 ]

5.  Secondary:   Improvement From Baseline in WOMAC VAS (Total Score)   [ Time Frame: Baseline and Week 13 ]

6.  Secondary:   Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response   [ Time Frame: Weeks 13 ]

7.  Secondary:   Improvement From Baseline in Subject Global Evaluations   [ Time Frame: Baseline and Week 13 ]

8.  Secondary:   Improvement From Baseline in Physician Global Evaluations   [ Time Frame: Baseline and Week 13 ]

9.  Secondary:   Acetaminophen Consumption   [ Time Frame: Week 9 to Week 13 ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
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.

Serious Adverse Events
    2Gel-200     1PBS1Gel-200  
Total, serious adverse events      
# participants affected / at risk     3/125 (2.40%)     1/74 (1.35%)  
Gastrointestinal disorders      
Ileus † 1    
# participants affected / at risk     0/125 (0.00%)     1/74 (1.35%)  
# events     0     1  
Injury, poisoning and procedural complications      
Femur fracture † 2    
# participants affected / at risk     1/125 (0.80%)     0/74 (0.00%)  
# events     1     0  
Lower limb fracture † 2    
# participants affected / at risk     0/125 (0.00%)     1/74 (1.35%)  
# events     0     1  
Musculoskeletal and connective tissue disorders      
Osteoarthritis † 2    
# participants affected / at risk     0/125 (0.00%)     1/74 (1.35%)  
# events     0     1  
Nervous system disorders      
Transient ischemic attack † 2    
# participants affected / at risk     1/125 (0.80%)     0/74 (0.00%)  
# events     1     0  
Respiratory, thoracic and mediastinal disorders      
Pulmonary mass † 2    
# participants affected / at risk     1/125 (0.80%)     0/74 (0.00%)  
# events     1     0  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 10.0
2 Term from vocabulary, MedDRA (10.0)




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information