PainPhase 3NCT00810121
Study of Non Inferiority Bi-Profenid® 200mg Versus Bi-Profenid® 300mg Among Patients Presenting of the Post-traumatic or Rheumatologic Acute Affections of the Locomotor Apparatus (BIPROPAIN)
A Phase 3 study testing ketoprofen 100 mg and ketoprofen in people with Pain, run by Sanofi at 1 site in France.
Trial summary
Primary objective: To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x 2 day in patients presenting with pain related to closed, benign, acute post-traumatic conditions of the motor system or acute, non-infectious rheumatologic conditions, by comparing, on the one hand, changes… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- ketoprofen 100 mg and ketoprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Jun 2009
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, more than 18 and less than 65 years of age,
- Women using a method of contraception and with a negative pregnancy test before entering the study, or women who have been menopausal for at least 1 year,
- Patients meeting one of the following criteria:
- Closed benign trauma of the motor system occurring within the last 24 hours,
- Contusion of the motor system occurring within the last 24 hours,
- Acute rheumatologic conditions (acute lower back pain, lumbar sciatica, cervicobrachial neuralgia),
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- Abarticular rheumatism,
- Requiring treatment with Bi-Profenid for 5 days,
- With resting pain intensity measured on a numeric scale at baseline >or= 3 (before administration of any treatment),
- Receiving a prior medical examination suited to the study
Who cannot join
- Need for surgery,
- Need for hospitalization,
- Need for an analgesic other than step I at the baseline visit,
- Need for treatment with another selective or non-selective NSAID (per os and/or topical), including aspirin, selective cyclo-oxygenase 2 inhibitors, corticosteroids or muscle relaxants at baseline and throughout the study,
- Serious trauma: knee luxation, any fracture, ruptures such as Achilles tendon rupture,
- Sprain treated with a cast,
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- Bursitis,
- Local and/or general severe infection,
- Pregnant or nursing women,
- Hypersensitivity to ketoprofen or to any of the excipients of the product,
- Previous history of asthma triggered by taking ketoprofen or substances with similar activity such as other NSAIDs or aspirin,
- Gastrointestinal haemorrhage, cerebrovascular haemorrhage or other active haemorrhage,
- Previous history of digestive haemorrhage or perforation during previous NSAID treatment,
- Active intestinal ulcer,
- Active peptic ulcer, previous history of peptic ulcer or recurrent haemorrhage (2 separate episodes or more of haemorrhage or ulcerations detected),
- Severe hepatic failure,
- Severe renal failure,
- Severe heart failure,
- Uncontrolled hypertension,
- Hypersensitivity or intolerance to gluten, due to the presence of wheat starch (gluten),
- Patients treated with oral anticoagulants, heparins, platelet antiaggregants, selective serotonin reuptake inhibitors (SSRI), lithium, methotrexate, pemetrexed and immunosuppressants
- 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: Non-inferiority Study of Bi-Profenid® 200 mg Versus Bi-Profenid® 300 mg in Patients Presenting With Pain Related to Closed, Benign, Acute Post-traumatic Conditions of the Motor System or Acute, Non-infectious Rheumatologic Conditions
Primary objective:
To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x 2 day in patients presenting with pain related to closed, benign, acute post-traumatic conditions of the motor system or acute, non-infectious rheumatologic conditions, by comparing, on the one hand, changes in resting pain intensity over the entire day, measured at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total intake over 5 days of concomitant analgesics.
Read more
Secondary Objectives:
- To describe concomitant analgesic treatments
- To describe the time between baseline and use of a step I, II or III analgesic
- To evaluate patients pain relief using a Likert 4-class scale (complete or substantial relief, moderate relief slight relief and absence of relief) at D5
- To evaluate changes in intensity of pain when moving, over the entire day, measured at the end of the day using a numeric scale, over 5 days
- To evaluate the patients overall satisfaction at the end of treatment using a 4-point Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
- To evaluate the patients overall satisfaction at the end of the study using a 4-point Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
- To compare the safety of the two treatments
- Conditions
- Pain
- Being tested
- ketoprofen 100 mg, ketoprofen
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoprofen 100 mgDrug
100 mg b.i.d. for 5 days
ketoprofenDrug
150 mg b.i.d. for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ketoprofen 100 mg b.i.d. for 5 days Receives: Drug: ketoprofen 100 mg |
| 2 | Experimental | Ketoprofen 150 mg b.i.d. for 5 days Receives: Drug: ketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting pain intensity measured using the numeric scale (NS) at the end of the day, and total intake of concomitant analgesics over 5 days. For these two parameters, the maximum value will be assigned to patients who used step II or III analgesics
Measured: between D1 and D5, at the end of the day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionJun 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marie Sebille, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810121
- Sponsor's protocol ID
- KETOP_L_03948
- Other IDs
- 2008-003375-41, 2008
- Status last verified
- Sep 2009
- First submitted
- 16 Dec 2008
- Last updated
- 25 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of Bi-Profenid® 200 mg Versus Bi-Profenid® 300 mg in Patients Presenting With Pain Related to Closed, Benign, Acute Post-traumatic Conditions of the Motor System or Acute, Non-infectious Rheumatologic Conditions
- ClinicalTrials.gov ID
- NCT00810121
- Acronym / sponsor ID
- KETOP_L_03948
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Dec 2008 (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 demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x 2 day in patients presenting with pain related to closed, benign, acute post-traumatic conditions of the motor system or acute, non-infectious rheumatologic conditions, by comparing, on the one hand, changes in resting pain intensity over the entire day, measured at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total intake over 5 days of concomitant analgesics.
Secondary Objectives:
- To describe concomitant analgesic treatments
- To describe the time between baseline and use of a step I, II or III analgesic
- To evaluate patients pain relief using a Likert 4-class scale (complete or substantial relief, moderate relief slight relief and absence of relief) at D5
- To evaluate changes in intensity of pain when moving, over the entire day, measured at the end of the day using a numeric scale, over 5 days
- To evaluate the patients overall satisfaction at the end of treatment using a 4-point Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
- To evaluate the patients overall satisfaction at the end of the study using a 4-point Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
- To compare the safety of the two treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ketoprofen 100 mgKetoprofen 100 mg b.i.d. for 5 days |
| 2 | Experimental | Drug: ketoprofenKetoprofen 150 mg b.i.d. for 5 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, more than 18 and less than 65 years of age,
- Women using a method of contraception and with a negative pregnancy test before entering the study, or women who have been menopausal for at least 1 year,
- Patients meeting one of the following criteria:
- Closed benign trauma of the motor system occurring within the last 24 hours,
- Contusion of the motor system occurring within the last 24 hours,
Key exclusion criteria (22 listed)
- Need for surgery,
- Need for hospitalization,
- Need for an analgesic other than step I at the baseline visit,
- Need for treatment with another selective or non-selective NSAID (per os and/or topical), including aspirin, selective cyclo-oxygenase 2 inhibitors, corticosteroids or muscle relaxants at baseline and throughout the study,
- Serious trauma: knee luxation, any fracture, ruptures such as Achilles tendon rupture,
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 |
|---|---|---|
| ketoprofen 100 mg100 mg b.i.d. for 5 days | Drug | 1 |
| ketoprofen150 mg b.i.d. for 5 days | Drug | 2 |
Primary outcome
Resting pain intensity measured using the numeric scale (NS) at the end of the day, and total intake of concomitant analgesics over 5 days. For these two parameters, the maximum value will be assigned to patients who used step II or III analgesics
Time frame: between D1 and D5, at the end of the day
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 25 Sep 2009.
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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.
Marie Sebille 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 ketoprofen 100 mg and ketoprofen in people with Pain, run by Sanofi at 1 site in France.
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 10 inclusion and 22 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 25 Sep 2009. 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 France. 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?
Resting pain intensity measured using the numeric scale (NS) at the end of the day, and total intake of concomitant analgesics over 5 days. For these two parameters, the maximum value will be assigned to patients who used step II or III analgesics (time frame: between D1 and D5, at the end of the day). 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 25 Sep 2009.