NCT00788710

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 22, 2011

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

November 5, 2008

Results QC Date

June 22, 2011

Last Update Submit

February 7, 2022

Conditions

Acute Pain Following a Total Abdominal Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 Days

Secondary Outcomes (2)

  • Average Total Daily Dose of Morphine Over Days 1 to 3

    3 days

  • Average Elicited Pain Upon Sitting Over Days 1 to 3

    3 days

Study Arms (3)

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.

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.

Drug: etoricoxib (MK0663) 90 mg

Placebo

PLACEBO COMPARATOR

Placebo- 3 tablets once daily

Drug: Comparator: Placebo

Interventions

etoricoxib (MK0663) 120 mgDRUG

120 mg of etoricoxib (MK0663) for a total of 5 days

Also known as: Arcoxia
Etoricoxib 120 mg
Comparator: PlaceboDRUG

Placebo tablets once daily on Days 1-5. Total treatment is 5 days.

Placebo
etoricoxib (MK0663) 90 mgDRUG

90 mg of etoricoxib (MK0663) for a total of 5 days

Etoricoxib 90 mg

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22738802DERIVED

MeSH Terms

Interventions

Etoricoxib

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 11, 2008

Study Start

October 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 9, 2022

Results First Posted

July 22, 2011

Record last verified: 2022-02