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Effectiveness of Celecoxib After Surgical Sperm Retrieval

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ClinicalTrials.gov Identifier: NCT01323595
Recruitment Status : Terminated (Interim analysis demonstrated significant benefit in intervention arm)
First Posted : March 25, 2011
Results First Posted : July 11, 2014
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Celecoxib
Drug: Sugar Pill
Enrollment 78
Recruitment Details Patients undergoing testicular sperm extraction surgery
Pre-assignment Details No exclusions except allergy to treatment agent (celecoxib)
Arm/Group Title Celecoxib Sugar Pill
Hide Arm/Group Description

Celecoxib will be given for 5 days after surgery

Celecoxib : Celecoxib 200mg PO BID x 6 days

Sugar pill for 5 days after surgery.

Sugar Pill : Sugar pill PO BID x 6 days

Period Title: Overall Study
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
Arm/Group Title Celecoxib Sugar Pill Total
Hide Arm/Group Description

Celecoxib will be given for 6 days after surgery

Celecoxib : Celecoxib 200mg PO BID x 6 days

Sugar pill for 6 days after surgery.

Sugar Pill : Sugar pill PO BID x 6 days

Total of all reporting groups
Overall Number of Baseline Participants 39 39 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 78 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
 100.0%
39
 100.0%
78
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 39 participants 78 participants
39  (5) 35  (5) 37  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 78 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
39
 100.0%
39
 100.0%
78
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 39 participants 78 participants
39 39 78
1.Primary Outcome
Title Level of Pain
Hide Description Patients will rate their pain for 7 days after surgery using an 11-point visual analog scale, ranging from 0 to 10, in which 0= no pain, 10=worst pain ever. Patients are asked to rate their pain up to four times a day during the post-operative period. Pain scores from each post-operative day each day will be averaged and reported as the pain score for that day.
Time Frame 1 week after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Treatment Celecoxib
Hide Arm/Group Description:
Patients received placebo medication
Patients received celecoxib
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: Analog pain scale
6  (2) 4  (2)
2.Secondary Outcome
Title Number of Participants With Bleeding Complications
Hide Description We will record whether there are any bleeding complications associated with treatment after surgery.
Time Frame 7 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Sugar Pill
Hide Arm/Group Description:

Celecoxib will be given for 6 days after surgery

Celecoxib: Celecoxib 200mg PO BID x 6 days

Sugar pill for 6 days after surgery.

Sugar Pill: Sugar pill PO BID x 6 days

Overall Number of Participants Analyzed 16 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Treatment Celecoxib
Hide Arm/Group Description Patients received placebo medication Patients received celecoxib
All-Cause Mortality
Placebo Treatment Celecoxib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Treatment Celecoxib
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Treatment Celecoxib
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chairman, Department of Urology
Organization: Weill Cornell Medical College
Phone: 212 746-5491
EMail: pnschleg@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01323595     History of Changes
Other Study ID Numbers: 1010011319
First Submitted: March 24, 2011
First Posted: March 25, 2011
Results First Submitted: October 29, 2013
Results First Posted: July 11, 2014
Last Update Posted: October 2, 2018