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Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection (TPESP2011-12)

This study has been completed.
Sponsor:
Collaborator:
Azienda Ospedaliera San Giovanni Battista
Information provided by (Responsible Party):
milva.battaglia, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT01652495
First received: July 21, 2012
Last updated: August 23, 2014
Last verified: August 2014
Results First Received: March 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Tendinopathy
Adrenal Insufficiency
Interventions: Drug: methylprednisolone acetate
Drug: Triamcinolone Acetonide

  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
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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
Methylprednisolone Acetate Group

Single intrabursal injection of methylprednisolone acetate

methylprednisolone acetate: Single intrabursal ultrasound guided injection

Triamcinolone Acetonide Group

Single intrabursal injection of Triamcinolone acetonide

Triamcinolone Acetonide: Single intrabursal ultrasound guided injection


Participant Flow:   Overall Study
    Methylprednisolone Acetate Group     Triamcinolone Acetonide Group  
STARTED     22     22  
COMPLETED     20     20  
NOT COMPLETED     2     2  



  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.
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Reporting Groups
  Description
Methylprednisolone Acetate Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate
Triamcinolone Acetonide Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide
Total Total of all reporting groups

Baseline Measures
    Methylprednisolone Acetate     Triamcinolone Acetonide     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  51.05  ± 6.67     46.35  ± 7.27     48.70  ± 7.29  
Gender  
[units: participants]
     
Female     14     8     22  
Male     6     12     18  
Region of Enrollment  
[units: participants]
     
Italy     20     20     40  



  Outcome Measures
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1.  Primary:   Functional Improvement Measured According to Percentage Change in Constant Score   [ Time Frame: 180 days after treatment ]

2.  Secondary:   Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis   [ Time Frame: 45 days after treatment ]

3.  Secondary:   Reduction of Pain Severity Expressed as Percentage Change in VAS Score   [ Time Frame: 180 days after treatment ]


  Serious Adverse Events


  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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Milva Battaglia, Director of Clinical Trials
Organization: Istituto Ortopedico Rizzoli
phone: 0516366026 ext 0039
e-mail: milva.battaglia@ior.it


Publications:

Responsible Party: milva.battaglia, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01652495     History of Changes
Other Study ID Numbers: 2012-000866-40
Study First Received: July 21, 2012
Results First Received: March 22, 2014
Last Updated: August 23, 2014
Health Authority: Italy: The Italian Medicines Agency