Trial Outcomes & Findings for Effectiveness of Celecoxib After Surgical Sperm Retrieval (NCT NCT01323595)
NCT ID: NCT01323595
Last Updated: 2018-10-02
Results Overview
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.
TERMINATED
NA
78 participants
1 week after surgery
2018-10-02
Participant Flow
Patients undergoing testicular sperm extraction surgery
No exclusions except allergy to treatment agent (celecoxib)
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
COMPLETED
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
23
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Celecoxib After Surgical Sperm Retrieval
Baseline characteristics by cohort
| Measure |
Celecoxib
n=39 Participants
Celecoxib will be given for 6 days after surgery
Celecoxib : Celecoxib 200mg PO BID x 6 days
|
Sugar Pill
n=39 Participants
Sugar pill for 6 days after surgery.
Sugar Pill : Sugar pill PO BID x 6 days
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 5 • n=5 Participants
|
35 years
STANDARD_DEVIATION 5 • n=7 Participants
|
37 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 week after surgeryPatients 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.
Outcome measures
| Measure |
Placebo Treatment
n=18 Participants
Patients received placebo medication
|
Celecoxib
n=16 Participants
Patients received celecoxib
|
|---|---|---|
|
Level of Pain
|
6 Analog pain scale
Standard Deviation 2
|
4 Analog pain scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 7 days after surgeryWe will record whether there are any bleeding complications associated with treatment after surgery.
Outcome measures
| Measure |
Placebo Treatment
n=16 Participants
Patients received placebo medication
|
Celecoxib
n=18 Participants
Patients received celecoxib
|
|---|---|---|
|
Number of Participants With Bleeding Complications
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo Treatment
Celecoxib
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chairman, Department of Urology
Weill Cornell Medical College
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place