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

NCT00971581 | Completed Phase 3

• 1 other identifier: KETOM_L_04584
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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)

Study Arms (1)

FDC KETOPROFEN+OMEPRAZOLE

EXPERIMENTAL

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

Drug: FDC KETOPROFEN+OMEPRAZOLE

Interventions

FDC KETOPROFEN+OMEPRAZOLE DRUG

Ketoprofen + Omeprazole FDC once daily for 4 weeks

FDC KETOPROFEN+OMEPRAZOLE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Col. Coyoacan, Mexico

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith Diaz

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

ME (1)