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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: FDC KETOPROFEN+OMEPRAZOLE

Study type

Interventional

Funder types

Industry

Identifiers

NCT00971581

KETOM_L_04584

Details and patient eligibility

About

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)

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.