Trial Outcomes & Findings for A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED) (NCT NCT00788710)
NCT ID: NCT00788710
Last Updated: 2022-02-09
Results Overview
Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
430 participants
Primary outcome timeframe
3 Days
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Etoricoxib 120 mg
Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
|
Etoricoxib 90 mg
Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
|
Placebo
Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
144
|
142
|
144
|
|
Overall Study
COMPLETED
|
139
|
134
|
138
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
6
|
Reasons for withdrawal
| Measure |
Etoricoxib 120 mg
Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
|
Etoricoxib 90 mg
Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
|
Placebo
Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
Baseline Characteristics
A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Etoricoxib 120 mg
n=144 Participants
Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
|
Etoricoxib 90 mg
n=142 Participants
Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
|
Placebo
n=144 Participants
Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
430 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 DaysPopulation: Full analysis set population
Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.
Outcome measures
| Measure |
Etoricoxib 120 mg
n=133 Participants
Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
|
Etoricoxib 90 mg
n=127 Participants
Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
|
Placebo
n=135 Participants
Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
|
|---|---|---|---|
|
Average Pain Intensity at Rest Over Days 1 to 3
|
2.40 Score on a scale
Standard Error 0.15
|
2.46 Score on a scale
Standard Error 0.15
|
3.26 Score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Full analysis set population
Outcome measures
| Measure |
Etoricoxib 120 mg
n=132 Participants
Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
|
Etoricoxib 90 mg
n=130 Participants
Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
|
Placebo
n=134 Participants
Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
|
|---|---|---|---|
|
Average Total Daily Dose of Morphine Over Days 1 to 3
|
5.37 milligrams (mg)
Standard Error 0.08
|
5.46 milligrams (mg)
Standard Error 0.08
|
7.75 milligrams (mg)
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Full analysis set population
Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.
Outcome measures
| Measure |
Etoricoxib 120 mg
n=133 Participants
Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
|
Etoricoxib 90 mg
n=127 Participants
Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
|
Placebo
n=135 Participants
Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
|
|---|---|---|---|
|
Average Elicited Pain Upon Sitting Over Days 1 to 3
|
3.58 Score on a scale
Standard Error 0.17
|
3.80 Score on a scale
Standard Error 0.17
|
4.71 Score on a scale
Standard Error 0.17
|
Adverse Events
Etoricoxib 120 mg
Serious events: 5 serious events
Other events: 60 other events
Deaths: 0 deaths
Etoricoxib 90 mg
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etoricoxib 120 mg
n=144 participants at risk
Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
|
Etoricoxib 90 mg
n=142 participants at risk
Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
|
Placebo
n=144 participants at risk
Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.69%
1/144 • Number of events 1
|
0.00%
0/142
|
0.00%
0/144
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/144
|
0.70%
1/142 • Number of events 1
|
0.00%
0/144
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.69%
1/144 • Number of events 1
|
0.00%
0/142
|
0.00%
0/144
|
|
Infections and infestations
Cellulitis
|
0.00%
0/144
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/144
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
|
Infections and infestations
Vaginal abscess
|
0.00%
0/144
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/144
|
0.70%
1/142 • Number of events 1
|
0.00%
0/144
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/144
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/144
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/144
|
0.70%
1/142 • Number of events 1
|
0.00%
0/144
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.69%
1/144 • Number of events 1
|
0.00%
0/142
|
0.00%
0/144
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer
|
0.69%
1/144 • Number of events 1
|
0.00%
0/142
|
0.00%
0/144
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/144
|
0.70%
1/142 • Number of events 1
|
0.00%
0/144
|
|
Nervous system disorders
Syncope
|
0.00%
0/144
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal haematoma
|
0.00%
0/144
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/144
|
0.70%
1/142 • Number of events 1
|
0.00%
0/144
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.69%
1/144 • Number of events 1
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/144
|
0.70%
1/142 • Number of events 1
|
0.00%
0/144
|
|
Vascular disorders
Hypertension
|
0.00%
0/144
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.00%
0/144
|
0.00%
0/142
|
0.69%
1/144 • Number of events 1
|
Other adverse events
| Measure |
Etoricoxib 120 mg
n=144 participants at risk
Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
|
Etoricoxib 90 mg
n=142 participants at risk
Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
|
Placebo
n=144 participants at risk
Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
11.1%
16/144 • Number of events 17
|
8.5%
12/142 • Number of events 13
|
12.5%
18/144 • Number of events 20
|
|
Gastrointestinal disorders
Flatulence
|
4.9%
7/144 • Number of events 7
|
9.9%
14/142 • Number of events 14
|
8.3%
12/144 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
27.8%
40/144 • Number of events 41
|
21.8%
31/142 • Number of events 35
|
26.4%
38/144 • Number of events 43
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
10/144 • Number of events 10
|
4.9%
7/142 • Number of events 7
|
6.9%
10/144 • Number of events 10
|
|
General disorders
Pyrexia
|
4.9%
7/144 • Number of events 7
|
2.8%
4/142 • Number of events 4
|
16.7%
24/144 • Number of events 27
|
|
Nervous system disorders
Dizziness
|
8.3%
12/144 • Number of events 12
|
6.3%
9/142 • Number of events 9
|
9.7%
14/144 • Number of events 14
|
|
Nervous system disorders
Headache
|
6.2%
9/144 • Number of events 11
|
5.6%
8/142 • Number of events 8
|
9.7%
14/144 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.5%
5/144 • Number of events 5
|
9.2%
13/142 • Number of events 14
|
4.2%
6/144 • Number of events 6
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER