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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971581
• Other study ID #: KETOM_L_04584
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2009
• Last updated: June 28, 2010
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• FDC KETOPROFEN+OMEPRAZOLE
Ketoprofen + Omeprazole FDC once daily for 4 weeks

Locations

Country	Name	City	State
Mexico	Sanofi-Aventis Administrative Office	Col. Coyoacan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To confirm the efficacy of the combination		From the start to the end of the study (D 0 to D 28)	No
Primary	Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea		At Day 10	Yes
Secondary	Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea		At Day 0, Day 4 & Day 28	Yes
Secondary	Incidence of complications (perforations, ulcers, bleeding) and Incidence of fecal occult blood positivity		At study termination (Day 28)	Yes
Secondary	Improvement of pain (VAS)		At study termination (Day 28)	No
Secondary	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)	Yes
Secondary	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)	No