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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00971581
First received: September 2, 2009
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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)

Condition Intervention Phase
Pain
Drug: FDC KETOPROFEN+OMEPRAZOLE
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To confirm the efficacy of the combination [ Time Frame: From the start to the end of the study (D 0 to D 28) ] [ Designated as safety issue: No ]
  • Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea [ Time Frame: At Day 10 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea [ Time Frame: At Day 0, Day 4 & Day 28 ] [ Designated as safety issue: Yes ]
  • Incidence of complications (perforations, ulcers, bleeding) and Incidence of fecal occult blood positivity [ Time Frame: At study termination (Day 28) ] [ Designated as safety issue: Yes ]
  • Improvement of pain (VAS) [ Time Frame: At study termination (Day 28) ] [ Designated as safety issue: No ]
  • Incidence of moderate to severe abdominal symptoms and GastroIntestinal Adverse Event leading to withdrawal [ Time Frame: From the start to the end of the study (D 0 to D 28) ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: At study termination (Day 28) ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971581

Locations
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Judith Diaz Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00971581     History of Changes
Other Study ID Numbers: KETOM_L_04584
Study First Received: September 2, 2009
Last Updated: June 28, 2010
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Additional relevant MeSH terms:
Ketoprofen
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014