NCT01190722

Brief Summary

The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_4

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2010

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2010

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

1 month

First QC Date

August 27, 2010

Last Update Submit

November 29, 2017

Conditions

Hallux ValgusPostoperative Pain

Keywords

Day case surgerypostoperative painNSAIDsCoxibs

Outcome Measures

Primary Outcomes (1)

  • Patients Global Evaluation of Study Medication

    Patients self-assessment of global satisfaction with pain medication

    postoperative day 1-6

Study Arms (2)

etoricoxib

EXPERIMENTAL

active study drug, coxib

Drug: etoricoxib

diclofenac

ACTIVE COMPARATOR

active traditional NSAID control

Drug: Diclofenac

Interventions

etoricoxibDRUG

120 mg once daily for the 1st 6 postoperative days

etoricoxib
DiclofenacDRUG

50 mg oral 3 times daily the 1st 6 postoperative days

diclofenac

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiology (ASA) physiological class 1-2 patients
  • aged 18-65 years
  • scheduled for elective hallux valgus surgery in general anesthesia

You may not qualify if:

  • NSAID allergy
  • liver disease
  • renal disease
  • uncontrolled cardiovascular disease
  • Lithium therapy
  • chronic pain
  • regular analgesia use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hallux ValgusPain, Postoperative

Interventions

EtoricoxibDiclofenac

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Jan Jakobsson, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adj. Professor

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 30, 2010

Study Start

November 10, 2010

Primary Completion

December 11, 2010

Study Completion

December 12, 2010

Last Updated

December 2, 2017

Record last verified: 2017-11