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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Operative Pain

Intervention: YM177 (Drug); etodolac (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

Summary

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

Clinical Details

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 --

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

Primary outcome: Patient impressions (4-categorical assessments)

Secondary outcome:

Pain intensity

Pain intensity difference

Discontinuation due to insufficient efficacy

Safety assessed by AE, clinical lab tests and vital signs

Detailed 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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Chubu, Japan

Chugoku, Japan

Hokkaido, Japan

Kansai, Japan

Kantou, Japan

Kyusyu, Japan

Shikoku, Japan

Touhoku, Japan

Additional Information

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

Starting date: February 2010
Last updated: October 14, 2014

Page last updated: August 23, 2015

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