NCT00738608

Brief Summary

The aim of this study is to demonstrate that compared to placebo the preoperative administration of a single dose of 120 mg etoricoxib can provide adequate pain relief in the postoperative phase while reducing the need for systemic opioids. The primary endpoint is the decrease of systemic opioid use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

3.2 years

First QC Date

August 18, 2008

Last Update Submit

September 17, 2009

Conditions

Pain

Keywords

morphineconsumptionpostoperativepainPain during 24h postoperativeMorphine consumption in 24h postoperative

Outcome Measures

Primary Outcomes (1)

  • Pain

    24h

Secondary Outcomes (1)

  • Pain drugs

    24h

Study Arms (2)

1

33 pat. with verum

2

33 Pat. with placebo

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

66 pat. with knee arthrosocpy

You may qualify if:

  • Knee arthroscopy

You may not qualify if:

  • Opiate addiction
  • Pregnancy or breast-feeding
  • Known hypersensitivity to the active substance or to any of the excipients of the film tablet
  • Active peptic ulcer or active gastrointestinal bleeding, inflammatory bowel disease, severe hepatic dysfunction (serum albumin \<25 g/l or Child-Pugh score ≥10).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marienkrankenhaus

Soest, 59494, Germany

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Lierz, MD

    Marienkrankenhaus Soest

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

June 1, 2006

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

DE(1)