Acute Pain Following a Total Abdominal HysterectomyPhase 3NCT00788710

A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)

A Phase 3 study testing etoricoxib (MK0663) 120 mg and etoricoxib (MK0663) 90 mg in people with Acute Pain Following a Total Abdominal Hysterectomy, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Acute Pain Following a Total Abdominal Hysterectomy
What is being tested?: etoricoxib (MK0663) 120 mg and etoricoxib (MK0663) 90 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 430 participants
Where: No sites listed yet
Study dates: Oct 2008to Jul 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption

Who cannot join

Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2) inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS
Patient has uncontrolled high blood pressure
Patient has a history of drug and/or alcohol abuse within the last 5 years
Patient has taken part in another investigational study within 4 weeks of the start of study
Patient is breast-feeding
Patient has an active ulcer or inflammatory bowel disease

About this study

Official title: A Double-Blind, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Tolerability of MK0663/Etoricoxib in the Treatment of Pain After Abdominal Hysterectomy

The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.

Conditions: Acute Pain Following a Total Abdominal Hysterectomy
Being tested: etoricoxib (MK0663) 120 mg, Comparator: Placebo, etoricoxib (MK0663) 90 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

etoricoxib (MK0663) 120 mgDrug
Also called Arcoxia
120 mg of etoricoxib (MK0663) for a total of 5 days
Comparator: PlaceboDrug
Placebo tablets once daily on Days 1-5. Total treatment is 5 days.
etoricoxib (MK0663) 90 mgDrug
90 mg of etoricoxib (MK0663) for a total of 5 days

Study groups in NCT00788710
Study group	Role	What they receive
Etoricoxib 120 mg	Experimental	etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days. Receives: Drug: etoricoxib (MK0663) 120 mg
Etoricoxib 90 mg	Experimental	etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days. Receives: Drug: etoricoxib (MK0663) 90 mg
Placebo	Placebo comparator	Placebo- 3 tablets once daily Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Pain Intensity at Rest Over Days 1 to 3
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.
Measured: 3 Days

Secondary outcomes (2)

Average Total Daily Dose of Morphine Over Days 1 to 3
Measured: 3 days
Average Elicited Pain Upon Sitting Over Days 1 to 3
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.
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Jul 2010

First posted11 Nov 2008 (estimated)
Study startOct 2008
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Pain Following a Total Abdominal HysterectomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 430 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00788710
Sponsor's protocol ID: 0663-097
Other IDs: 2008_578
Status last verified: Feb 2022
First submitted: 5 Nov 2008
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Viscusi ER, Frenkl TL, Hartrick CT, Rawal N, Kehlet H, Papanicolaou D, Gammaitoni A, Ko AT, Morgan LM, Mehta A, Curtis SP, Peloso PM. Perioperative use of etoricoxib reduces pain and opioid side-effects after total abdominal hysterectomy: a double-blind, randomized, placebo-controlled phase III study. Curr Med Res Opin. 2012 Aug;28(8):1323-35. doi: 10.1185/03007995.2012.707121. Epub 2012 Jul 16.
PubMed 22738802

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Tolerability of MK0663/Etoricoxib in the Treatment of Pain After Abdominal Hysterectomy
ClinicalTrials.gov ID: NCT00788710
Acronym / sponsor ID: 0663-097
Conditions: Acute Pain Following a Total Abdominal Hysterectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 430 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 11 Nov 2008 (estimated)
Results: Posted 22 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Etoricoxib 120 mg	Experimental	Drug: etoricoxib (MK0663) 120 mgetoricoxib (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	Experimental	Drug: etoricoxib (MK0663) 90 mgetoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
Placebo	Placebo comparator	Drug: Comparator: PlaceboPlacebo- 3 tablets once daily

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption

Key exclusion criteria (6 listed)

Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2) inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS
Patient has uncontrolled high blood pressure
Patient has a history of drug and/or alcohol abuse within the last 5 years
Patient has taken part in another investigational study within 4 weeks of the start of study
Patient is breast-feeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
etoricoxib (MK0663) 120 mgAlso: Arcoxia120 mg of etoricoxib (MK0663) for a total of 5 days	Drug	Etoricoxib 120 mg
Comparator: PlaceboPlacebo tablets once daily on Days 1-5. Total treatment is 5 days.	Drug	Placebo
etoricoxib (MK0663) 90 mg90 mg of etoricoxib (MK0663) for a total of 5 days	Drug	Etoricoxib 90 mg

Primary outcome

Average Pain Intensity at Rest Over Days 1 to 3
Time frame: 3 Days
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.

2 secondary outcomes

Average Total Daily Dose of Morphine Over Days 1 to 3
Time frame: 3 days
Average Elicited Pain Upon Sitting Over Days 1 to 3
Time frame: 3 days

Results and safety

Results posted to the registry on 22 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etoricoxib 120 mg	144	139
Etoricoxib 90 mg	142	134
Placebo	144	138

Primary outcome: Average Pain Intensity at Rest Over Days 1 to 3

Time frame: 3 Days. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Etoricoxib 120 mg n = 133	Etoricoxib 90 mg n = 127	Placebo n = 135
Value	2.40 (0.15)	2.46 (0.15)	3.26 (0.15)

Etoricoxib 120 mg vs Placebo: p <0.001, ANOVA
Etoricoxib 90 mg vs Placebo: p <0.001, ANOVA

Population analysed: Full analysis set population

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etoricoxib 120 mg	5 of 144 (3.5%)	60 of 144 (41.7%)	Not reported
Etoricoxib 90 mg	5 of 142 (3.5%)	51 of 142 (35.9%)	Not reported
Placebo	10 of 144 (6.9%)	65 of 144 (45.1%)	Not reported

Limitations and caveats (from the sponsor): 11 participants were screened \& 10 participants were randomized at site 0028. An audit showed study medication dispensing logs were not kept. These 10 participants were invalidated and excluded from both efficacy \& safety analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22738802Viscusi ER, Frenkl TL, Hartrick CT, Rawal N, Kehlet H, Papanicolaou D, Gammaitoni A, Ko AT, Morgan LM, Mehta A, Curtis SP, Peloso PM. Perioperative use of etoricoxib reduces pain and opioid side-effects after total abdominal hysterectomy: a double-blind, randomized, placebo-controlled phase III study. Curr Med Res Opin. 2012 Aug;28(8):1323-35. doi: 10.1185/03007995.2012.707121. Epub 2012 Jul 16.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing etoricoxib (MK0663) 120 mg and etoricoxib (MK0663) 90 mg in people with Acute Pain Following a Total Abdominal Hysterectomy, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Pain Intensity at Rest Over Days 1 to 3 (time frame: 3 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00788710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.