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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;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis of the Knee
Intervention: Device: Gel-200

  Participant Flow
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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
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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 
Overall Participants Analyzed 
[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) 
[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.
WOMAC VAS Stiffness Subscore [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 69.7  (18.31)   70.7  (18.40)   70.1  (18.30) 
[1] 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.
WOMAC VAS Physical Function Subcore [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 68.0  (17.96)   69.9  (16.35)   68.7  (17.35) 
[1] 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.
WOMAC VAS Total Score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 68.4  (17.07)   69.9  (15.79)   69.0  (16.58) 
[1] 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.
Subject Global Evaluations [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 66.1  (21.81)   68.2  (18.85)   66.9  (20.70) 
[1] 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.
Physician Global Evaluations [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 60.5  (16.85)   62.6  (20.51)   61.3  (18.29) 
[1] 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
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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
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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
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  More Information