NCT01876121

Brief Summary

This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
784

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

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

July 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

June 10, 2013

Last Update Submit

September 4, 2014

Conditions

Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain

Keywords

NSAIDsAcute pain

Outcome Measures

Primary Outcomes (1)

  • Safety assessed by the incidence of adverse events and lab-tests

    For 2 weeks

Secondary Outcomes (1)

  • Overall pain improvement assessed by visual analogue scale (VAS)

    Baseline and week-2

Study Arms (1)

Celecox group

Drug: Celecoxib

Interventions

CelecoxibDRUG

oral

Also known as: Celecox
Celecox group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with traumatic pain, post-surgical pain and tooth extract pain

You may qualify if:

  • Patients with traumatic pain, post-surgical pain and tooth extract pain

You may not qualify if:

  • Hyperreactive to sulfonamide
  • Aspirin asthma patients
  • Peptidic ulcer patients
  • Serious liver disease patients
  • Serious kidney disease patients
  • Serious heart failure patients
  • End of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Pain, PostoperativeAcute Pain

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

July 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

JP(7)