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Safety of Lumiracoxib in Patients With Osteoarthritis

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

Condition(s) targeted: Osteoarthritis

Intervention: lumiracoxib (Device); rofecoxib (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Summary

This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator

Clinical Details

Official title: A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral Edema in Subjects With Primary Osteoarthritis Treated With COX189 400 mg o-do Using Rofecoxib 25 mg o.d. as a Comparator

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

Primary outcome: Incidence of at least one of seven predefined gastrointestinal adverse events

Eligibility

Minimum age: 50 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age >=50 years old

- Primary osteoarthritis in hip, hand, knee or spine for at least 3 month

- Pain in the target joint of moderate intensity

- Written informed consent

Exclusion Criteria:

- Secondary osteoarthritis

- Active upper gastro intestinal tract ulceration

- Inflammatory joint disease

- Gout

- Clinically significant hepatic or renal disease

Other in and exclusion criteria may apply

Locations and Contacts

Additional Information

Starting date: December 2000
Last updated: March 17, 2008

Page last updated: August 23, 2015

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