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Celecoxib as a Post-tonsillectomy Pain Medication

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ClinicalTrials.gov Identifier: NCT00583453
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Douglas J Van Daele, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Tonsillitis
Interventions Drug: Celecoxib
Drug: Placebo
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celecoxib as Experimerimental Intervention Placebo Control, Active Comparator
Hide Arm/Group Description

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Period Title: Overall Study
Started 9 8
Completed 9 6
Not Completed 0 2
Reason Not Completed
discontinued intervention             0             2
Arm/Group Title Celecoxib 200 mg Tablets Placebo With Same Dosing Schedule as the Active Comparator Arm Total
Hide Arm/Group Description

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Total of all reporting groups
Overall Number of Baseline Participants 9 8 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
8
 100.0%
17
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 8 participants 17 participants
25.1  (4.1) 25.0  (3.3) 25.0  (3.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
Female
8
  88.9%
7
  87.5%
15
  88.2%
Male
1
  11.1%
1
  12.5%
2
  11.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 8 participants 17 participants
9 8 17
1.Primary Outcome
Title Self-reported Pain Score
Hide Description Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.
Time Frame day of procedure through post-operative day 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib 200 mg Tablets Placebo With Same Dosing Schedule as the Active Comparator Arm
Hide Arm/Group Description:

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Overall Number of Participants Analyzed 9 6
Mean (Standard Error)
Unit of Measure: pain score (units on a scale)
Maximum pain, day 1 5.0  (0.6) 6.0  (0.7)
maximum pain, averaged across days 2 to 4 5.1  (0.6) 6.0  (0.7)
maximum pain, averaged across days 5 to 7 4.4  (0.6) 5.9  (0.7)
maximum pain, averaged across days 8 to 10 3.6  (0.6) 4.0  (0.7)
Average pain, day 1 6.1  (1.0) 7.3  (0.8)
Average pain, averaged across days 2 to 4 6.2  (0.9) 7.6  (0.8)
Average pain, averaged across days 5 to 7 6.1  (0.9) 7.4  (0.8)
Average pain, averaged across days 8 to 10 4.9  (0.9) 5.7  (0.8)
Pain with drinking, day 1 5.7  (0.9) 6.7  (0.8)
Pain with drinking, averaged across days 2 to 4 5.4  (0.8) 6.6  (0.7)
Pain with drinking, averaged across days 5 to 7 4.9  (0.8) 5.9  (0.7)
Pain with drinking, averaged across days 8 to 10 3.9  (0.8) 4.1  (0.7)
Activity, day 1 2.8  (0.9) 4.5  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg Tablets, Placebo With Same Dosing Schedule as the Active Comparator Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .674
Comments Treatment x day interaction
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Self-reported Activity Level
Hide Description Activity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily.
Time Frame From operative day through 10 days post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib as Experimerimental Intervention Placebo Control, Active Comparator
Hide Arm/Group Description:

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Overall Number of Participants Analyzed 9 6
Mean (Standard Error)
Unit of Measure: Activity score (units on a scale)
Day 1 2.8  (0.9) 4.5  (1.0)
Average, days 2 to 4 3.1  (0.7) 4.1  (0.9)
Average, days 5 to 7 5.4  (0.7) 3.7  (0.9)
Average, days 8 to 10 7.4  (0.7) 5.7  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib as Experimerimental Intervention, Placebo Control, Active Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Treatment x day interaction reported as 0.018.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Acetaminophen Equivalent Use
Hide Description Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.
Time Frame From operative day through 10 days post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib as Experimerimental Intervention Placebo Control, Active Comparator
Hide Arm/Group Description:

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Overall Number of Participants Analyzed 9 6
Mean (Standard Error)
Unit of Measure: mg
Day 1 2074  (407) 3006  (498)
Average, days 2 to 4 2245  (356) 2934  (436)
Average, days 5 to 7 2028  (356) 3610  (436)
Average, days 8 to 10 1418  (356) 2483  (436)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib as Experimerimental Intervention, Placebo Control, Active Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .214
Comments Treatment x day interaction = 0.214
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Incidence of Post-operative Hemorrhage
Hide Description The incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period.
Time Frame From operative day through 10 days post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib 200 mg Tablets Placebo With Same Dosing Schedule as the Active Comparator Arm
Hide Arm/Group Description:

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Overall Number of Participants Analyzed 9 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Total Morphine Equivalent
Hide Description Participant reported mophine equivalent use
Time Frame From operative day through 10 days post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib as Experimerimental Intervention Placebo Control, Active Comparator
Hide Arm/Group Description:

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Overall Number of Participants Analyzed 9 6
Mean (Standard Error)
Unit of Measure: mg
Day 1 28.9  (11.6) 55.0  (14.2)
Average, days 2 to 4 30.4  (9.6) 72.4  (11.7)
Average, days 5 to 7 27.8  (9.6) 69.7  (11.7)
Average, days 8 to 10 13.2  (9.6) 38.3  (11.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib as Experimerimental Intervention, Placebo Control, Active Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments treatment x day interaction P = 0.036 Treatment main effect (average day 1 to 10) P = 0.003
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 3 weeks postoperatively
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib as Experimerimental Intervention Placebo Control, Active Comparator
Hide Arm/Group Description

Celecoxib 200 mg tablets

Celecoxib: Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Placebo with same dosing schedule as the active comparator arm

Placebo: Placebo capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

All-Cause Mortality
Celecoxib as Experimerimental Intervention Placebo Control, Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib as Experimerimental Intervention Placebo Control, Active Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celecoxib as Experimerimental Intervention Placebo Control, Active Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      2/6 (33.33%)    
Gastrointestinal disorders     
Vomiting, grade 1 * 1 [1]  1/9 (11.11%)  5 2/6 (33.33%)  2
Dysphagia, grade 2 * 1 [2]  0/9 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders     
Dehydration, grade 2 * 1 [3]  0/9 (0.00%)  0 2/6 (33.33%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
[2]
A disorder characterized by difficulty in swallowing. Grade 2 = symptomatic and altered eating / swallowing
[3]
A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or lack of adequate fluid intake. Grade 2: I.V. fluids indicated for less than 24 hours
Small sample size Disproportionately female population
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
Layout table for Results Point of Contact information
Name/Title: Douglas Van Daele
Organization: University of Iowa
Phone: 319-353-8162
EMail: douglas-van-daele@uiowa.edu
Layout table for additonal information
Responsible Party: Douglas J Van Daele, University of Iowa
ClinicalTrials.gov Identifier: NCT00583453     History of Changes
Other Study ID Numbers: 200703765
First Submitted: December 20, 2007
First Posted: December 31, 2007
Results First Submitted: February 12, 2017
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017