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

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 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)
Measure Description 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.
Time Frame Baseline and Week 13  
Safety Issue No  

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.
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.

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.

Measured Values
    2Gel-200     1PBS1Gel-200  
Number of Participants Analyzed  
[units: participants]
 		  122     74  
Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)  
[units: millimeters]
Mean ± Standard Deviation 		  32.3  ± 22.68     35.4  ± 22.97  


Statistical Analysis 1 for Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)
Groups [1] 2Gel-200
Method [2] t-test, 2 sided
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)
Groups [1] 1PBS1Gel-200
Method [2] t-test, 2 sided
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

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

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

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

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

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

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Clinical Development Dept.
Organization: Seikagaku Corporation
phone: 81-3-5220-8950
e-mail: hiroyuki.hosokawa@seikagaku.co.jp


No publications provided


Responsible Party: Osamu Akahane, Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT00450112     History of Changes
Other Study ID Numbers: Gel/1132
Study First Received: March 20, 2007
Results First Received: April 15, 2011
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration