Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole

NCT ID: NCT00971581

Last Updated: 2010-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-05-31

Brief Summary

Primary Objective:

To confirm the safety and tolerability of the fixed dose combination of a Non-Steroidal Anti-Inflammatory Drug (NSAID), ketoprofen, associated to a Proton Pump Inhibitor (PPI), omeprazole, in Mexican patients.

Secondary Objective:

To confirm the efficacy of the combination:

• Relief of pain (Visual Analyzed Score (VAS))
• Patients global assessment of disease activity, scored as a scale of 1 (no limitation of normal activities) to 5 (inability to carried out all normal activities)

Conditions

Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FDC KETOPROFEN+OMEPRAZOLE

One capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks

Group Type: EXPERIMENTAL

FDC KETOPROFEN+OMEPRAZOLE

Intervention Type: DRUG

Ketoprofen + Omeprazole FDC once daily for 4 weeks

Interventions

FDC KETOPROFEN+OMEPRAZOLE

Ketoprofen + Omeprazole FDC once daily for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults suffering from chronic inflammatory conditions, in particular, rheumatoid polyarthritis, ankylosing spondylitis (or related syndromes, such as, Reiters syndrome, psoriatic arthritis,) with a previous history or who are at risk of developing NSAID associated benign gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with NSAIDs is necessary.
• Presenting at the inclusion visit an acute episode of recent onset (<48 hours) defined by average pain within the last 24 hours >=50 mm on the Visual Analogue Scale (VAS).

Exclusion Criteria

• Hypersensitivity to ketoprofen or to omeprazole or to another proton-pump inhibitor or to any of the excipients.
• Last trimester of pregnancy.
• History of asthma induced by administration of ketoprofen or similar acting substances, such as other non-steroidal anti-inflammatory agents (NSAIDs) or acetylsalicylic acid.
• Gastrointestinal disorder or surgery leading to impaired drug absorption.
• Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would endanger a subject if they were to participate in the study.
• Serious blood coagulation disorder including use of systemic anticoagulants.
• Positive test result for H. pylori at screening.
• Recent endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth.
• Severe hepatic failure.
• Severe renal failure.
• Severe heart failure.
• Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis.
• Active peptic ulcer.
• Gastrointestinal bleeding, cerebrovascular bleeding or other active bleeding.
• Alcohol consumption or drug abuse.
• Concomitant use with St. Johns wort or atazanavir sulphate.
• Concomitant use of the following medications:

• NSAIDs including cyclooxygenase-2 selective inhibitors
• Salicylates
• Corticosteroids
• DMARDs
• Antacids
• Histamine H2 receptors
• Misoprostol
• Other PPI
• Sucralfate
• Anticoagulants: Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs)
• Lithium:
• Methotrexate (at doses above 15 mg/week):
• Screening laboratory value for ALT, AST >2 times the upper limit of normal.
• Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if they were to participate in the study.
• History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
• Participation in any study of an investigational treatment in the 8 weeks before screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Judith Diaz

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Col. Coyoacan, , Mexico

Countries

Mexico

Other Identifiers

KETOM_L_04584

Identifier Type: -

Identifier Source: org_study_id