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

Safety, Tolerability and Efficacy of FDC Ketoprofen + Omeprazole in Patients With Rheumatological Conditions With History or Who Are at Risk of Developing NSAID Associated Benign Gastric Ulcers, Duodenal Ulcers and Gastroduodenal Erosions

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)

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: FDC KETOPROFEN+OMEPRAZOLE

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Col. Coyoacan, Mexico
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FDC KETOPROFEN+OMEPRAZOLE; One capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks	Drug: FDC KETOPROFEN+OMEPRAZOLE; Ketoprofen + Omeprazole FDC once daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To confirm the efficacy of the combination	From the start to the end of the study (D 0 to D 28)
Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea	At Day 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea	At Day 0, Day 4 & Day 28
Incidence of complications (perforations, ulcers, bleeding) and Incidence of fecal occult blood positivity	At study termination (Day 28)
Improvement of pain (VAS)	At study termination (Day 28)
Incidence of moderate to severe abdominal symptoms and GastroIntestinal Adverse Event leading to withdrawal	From the start to the end of the study (D 0 to D 28)
Patient's 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)	At study termination (Day 28)

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Judith Diaz, Sanofi

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: September 2, 2009
• First Submitted That Met QC Criteria: September 2, 2009
• First Posted (Estimate): September 3, 2009

Study Record Updates

• Last Update Posted (Estimate): June 29, 2010
• Last Update Submitted That Met QC Criteria: June 28, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole; Ketoprofen
• Other Study ID Numbers: KETOM_L_04584