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A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Capstone Therapeutics
ClinicalTrials.gov Identifier:
NCT00811577
First received: December 18, 2008
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
Results First Received: May 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Scar Prevention
Scar Reduction
Interventions: Drug: Placebo
Drug: AZX100

  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
Enrollment in the study began in January 2009 and was completed in December 2009. All patients were enrolled in dermatological medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AZX100-Placebo Arm Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
Placebo-only Arm Three trocar sites on each patient will receive one dose of placebo.

Participant Flow:   Overall Study
    AZX100-Placebo Arm     Placebo-only Arm  
STARTED     126     24  
COMPLETED     116     23  
NOT COMPLETED     10     1  
Lost to Follow-up                 7                 1  
Withdrawal by Subject                 3                 0  



  Baseline Characteristics
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Reporting Groups
  Description
AZX100-Placebo Arm Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
Placebo-only Arm Three trocar sites on each patient will receive one dose of placebo.
Total Total of all reporting groups

Baseline Measures
    AZX100-Placebo Arm     Placebo-only Arm     Total  
Number of Participants  
[units: participants]
 		  126     24     150  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     112     19     131  
>=65 years     14     5     19  
Age  
[units: years]
Mean ± Standard Deviation 		  51.3  ± 11.8     51.8  ± 13.2     51.4  ± 12.0  
Gender  
[units: participants]
 		     
Female     36     7     43  
Male     90     17     107  
Region of Enrollment  
[units: participants]
 		     
United States     126     24     150  



  Outcome Measures
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1.  Primary:   Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores   [ Time Frame: 12 months ]
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2.  Secondary:   Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography   [ Time Frame: 12 months ]
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3.  Secondary:   Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)   [ Time Frame: 12 months ]
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4.  Secondary:   Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)   [ Time Frame: 12 months ]
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5.  Secondary:   Histological Evaluation of Collagen   [ Time Frame: 12 months ]
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6.  Secondary:   Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells   [ Time Frame: 12 months ]
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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: Denise Lamon
Organization: Capstone Therapeutics Corp.
phone: 602-286-5206
e-mail: dlamon@capstonethx.com


No publications provided


Responsible Party: Capstone Therapeutics
ClinicalTrials.gov Identifier: NCT00811577     History of Changes
Other Study ID Numbers: OL-ASCAR-03
Study First Received: December 18, 2008
Results First Received: May 16, 2012
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration