Effectiveness of Celecoxib After Surgical Sperm Retrieval

This study has been terminated.
(Interim analysis demonstrated significant benefit in intervention arm)
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01323595
First received: March 24, 2011
Last updated: June 10, 2014
Last verified: June 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Celecoxib
Drug: Sugar Pill

  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
Patients undergoing testicular sperm extraction surgery

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No exclusions except allergy to treatment agent (celecoxib)

Reporting Groups
  Description
Celecoxib

Celecoxib will be given for 5 days after surgery

Celecoxib : Celecoxib 200mg PO BID x 6 days

Sugar Pill

Sugar pill for 5 days after surgery.

Sugar Pill : Sugar pill PO BID x 6 days


Participant Flow:   Overall Study
    Celecoxib     Sugar Pill  
STARTED     39     39  
COMPLETED     16 [1]   18 [2]
NOT COMPLETED     23     21  
[1] Remaining subjects did not return questionnaire
[2] Remaining subjects did not return questionaire



  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
Celecoxib

Celecoxib will be given for 6 days after surgery

Celecoxib : Celecoxib 200mg PO BID x 6 days

Sugar Pill

Sugar pill for 6 days after surgery.

Sugar Pill : Sugar pill PO BID x 6 days

Total Total of all reporting groups

Baseline Measures
    Celecoxib     Sugar Pill     Total  
Number of Participants  
[units: participants]
  39     39     78  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     39     39     78  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  39  ± 5     35  ± 5     37  ± 5  
Gender  
[units: participants]
     
Female     0     0     0  
Male     39     39     78  
Region of Enrollment  
[units: participants]
     
United States     39     39     78  



  Outcome Measures

1.  Primary:   Level of Pain   [ Time Frame: 1 week after surgery ]

2.  Secondary:   Bleeding Complications   [ Time Frame: 7 days after surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Chairman, Department of Urology
Organization: Weill Cornell Medical College
phone: 212 746-5491
e-mail: pnschleg@med.cornell.edu


No publications provided


Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01323595     History of Changes
Other Study ID Numbers: 1010011319
Study First Received: March 24, 2011
Results First Received: October 29, 2013
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board