A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients

Post Operative Pain Clinical Trial

Official title:

A Phase III Study of YM177 (Postoperative Pain) -- An Etodolac- and Placebo-controlled, Multicenter, Double-blind, Group Comparison Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients --

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118572
• Other study ID #: 177-CL-102
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2010
• Last updated: October 14, 2014
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: October 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.

Description:

To verify the superiority to placebo and the noninferiority to etodolac of YM177 in terms of efficacy assessment in patients with postoperative pain. Also, to compare them in terms of safety assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 616
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with spontaneous pain within 24 hours postoperatively

• The intensity of the pain:

• 4-categorical assessment: "Moderate pain" or "Severe pain"

• VAS assessment: 45.0 mm or higher

• Patients whose postoperative pain can be managed using an oral NSAID

Exclusion Criteria:

• A past history of aspirin-induced asthma

• A past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease

• Patients who undergoes the surgical procedure under general anesthesia

• Patients taking excluded medications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• YM177
oral
• etodolac
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient impressions (4-categorical assessments)		For 2 days	No
Secondary	Pain intensity		For 2 days	No
Secondary	Pain intensity difference		For 2 days	No
Secondary	Discontinuation due to insufficient efficacy		For 2 days	No
Secondary	Safety assessed by AE, clinical lab tests and vital signs		For 2 days	No

External Links

•   Link to Results on JAPIC - enter 140636 in the JapicCTI-RNo. field (Japanese record)