PainPhase 3NCT00971581
Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole
A Phase 3 study testing FDC KETOPROFEN+OMEPRAZOLE in people with Pain, run by Sanofi at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- FDC KETOPROFEN+OMEPRAZOLE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2009to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 34Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- FDC KETOPROFEN+OMEPRAZOLE
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC KETOPROFEN+OMEPRAZOLEDrug
Ketoprofen + Omeprazole FDC once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| FDC KETOPROFEN+OMEPRAZOLE | Experimental | One capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks Receives: Drug: FDC KETOPROFEN+OMEPRAZOLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the efficacy of the combination
Measured: From the start to the end of the study (D 0 to D 28)
Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea
Measured: At Day 10
Secondary outcomes (5)
Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea
Measured: At Day 0, Day 4 & Day 28
Incidence of complications (perforations, ulcers, bleeding) and Incidence of fecal occult blood positivity
Measured: At study termination (Day 28)
Improvement of pain (VAS)
Measured: At study termination (Day 28)
Incidence of moderate to severe abdominal symptoms and GastroIntestinal Adverse Event leading to withdrawal
Measured: 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)
Measured: At study termination (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Judith Diaz, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971581
- Sponsor's protocol ID
- KETOM_L_04584
- Status last verified
- Jun 2010
- First submitted
- 2 Sep 2009
- Last updated
- 29 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00971581
- Acronym / sponsor ID
- KETOM_L_04584
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDC KETOPROFEN+OMEPRAZOLE | Experimental | Drug: FDC KETOPROFEN+OMEPRAZOLEOne capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDC KETOPROFEN+OMEPRAZOLEKetoprofen + Omeprazole FDC once daily for 4 weeks | Drug | FDC KETOPROFEN+OMEPRAZOLE |
Primary outcome
To confirm the efficacy of the combination
Time frame: From the start to the end of the study (D 0 to D 28)
Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea
Time frame: At Day 10
5 secondary outcomes
Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea
Time frame: At Day 0, Day 4 & Day 28
Incidence of complications (perforations, ulcers, bleeding) and Incidence of fecal occult blood positivity
Time frame: At study termination (Day 28)
Improvement of pain (VAS)
Time frame: At study termination (Day 28)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
Related trials for Pain
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
Active, not recruiting
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Not yet recruitingPhase 4
Methylprednisolone Taper is an Effective Addition to Multimodal Pain Regimens After Rotator Cuff Repair
Shoulder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Diaz study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FDC KETOPROFEN+OMEPRAZOLE in people with Pain, run by Sanofi at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To confirm the efficacy of the combination (time frame: From the start to the end of the study (D 0 to D 28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010; AzTrials last refreshed its copy on 29 Oct 2026.