Safety of Lumiracoxib in Patients With Osteoarthritis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00637949

Purpose

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

Condition	Intervention	Phase
Osteoarthritis	Device: lumiracoxib Drug: rofecoxib	Phase III

MedlinePlus related topics: Edema Osteoarthritis

Drug Information available for: Rofecoxib Lumiracoxib

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of at least one of seven predefined gastrointestinal adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	309
Study Start Date:	December 2000
Study Completion Date:	March 2001
Primary Completion Date:	March 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: lumiracoxib 400 mg once daily, oral over 6 weeks
2: Active Comparator	Drug: rofecoxib 25 mg, oral, daily over 6 weeks

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Stricker K, Yu S, Krammer G. A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients. BMC Musculoskelet Disord. 2008 Sep 8;9:118.

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CCOX189A2307
Study First Received:	March 11, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00637949 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Osteoarthritis
lumiracoxib
rofecoxib
Cox-2
Osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)

Study placed in the following topic categories:

Prexige
Anti-Inflammatory Agents
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Edema
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Rofecoxib
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prexige
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Pharmacologic Actions

Musculoskeletal Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Arthritis
Rofecoxib
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009