PainPhase 3NCT00929877
KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges
A Phase 3 study testing KETOPROFEN(RP19583) in people with Pain, run by Sanofi at 7 sites in 7 countries.
Trial summary
Primary Objective: To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120) after the first intake of study drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- KETOPROFEN(RP19583)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 801 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Jun 2009to Apr 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
- Patients with a sore throat associated or not with an URTI > or = 24 hours and < or = 6 days' duration, in the absence of A.Streptococcus*,
- Evidence of tonsillo-pharyngitis (TPA score > or = 5) at inclusion,
- With a score of throat soreness > or = 6 (0-10 ordinal scale),
- With a perception of swollen throat > or = 60mm (VAS),
- With a global throat pain intensity such as pain at swallowing
- assessed by a VAS > or = 60 mm.
Show all 9Show fewer
- Specific exploration at Inclusion:
- The Score of Mac Isaac will be performed by the investigator.
- Presence of streptococcus will be assessed by a throat swab test Patients having a positive swab test will not be included.
Who cannot join
- Patients having used any local medication containing a local oral anesthetic such as lozenge, spray, mouth rinse or any topical throat treatment within 2 hours before study entry
- Patients with positive throat swab test for A.Streptococcus pharyngitis
- Patients having used analgesics within 4 hours before study entry
- Patients having used any long-acting or slow release analgesics within 12 hours before study entry
- Patients having used any anti inflammatory treatment 8-12 hours before study entry
- Patients having used any anti histaminic 8-12 hours before study entry
Show all 16Show fewer
- Patients with pharyngeal paresthesia
- Patients with pharyngeal mycosis
- Patients with known history of ketoprofen, aspirin or other NSAID-induced bronchospasm
- Hypersensitivity to ketoprofen or its excipients
- Any disease that could compromise breathing such as bronchopneumonia or asthma
- Evidence of mouth-breathing or uncomfortable coughing
- Any chronic disease that requires a long period anti-inflammatory treatment
- Any chronic disease that requires long term use of anticoagulants or use of anticoagulants or anti-platelet agents one week before study entry,
- Women known to be pregnant.
- 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
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: A Randomised Double Blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of 2 Doses of Ketoprofen Lysinate Lozenges (6.25 mg & 12.5 mg) in Patients With Sore Throat
Primary Objective:
To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120) after the first intake of study drug.
Read more
Secondary Objectives:
To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with placebo after the first intake on:
- the total pain relief summed over 15 to 360min (TOTPAR15-360)
- the changes from baseline of global throat pain intensity assessed over 15 to 120min and over 15 to 360min.
- the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min
- the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To compare pain relief, global throat pain intensity, throat soreness and swollen throat in the evening of days 1, 2 and 3
To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at follow-up visit on:
Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed by a clinical examination if needed)
- Conditions
- Pain
- Being tested
- KETOPROFEN(RP19583), Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KETOPROFEN(RP19583)Drug
Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
KETOPROFEN(RP19583)Drug
Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
PlaceboDrug
Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
| Study group | Role | What they receive |
|---|---|---|
| Ketoprofen lysinate 12.5 mg | Experimental | Not described Receives: Drug: KETOPROFEN(RP19583) |
| Ketoprofen lysinate 6.25 mg | Experimental | Not described Receives: Drug: KETOPROFEN(RP19583) |
| Matching placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The TOTPAR15-120 which is the sum of each pain relief scale score
Measured: measured every 15 minutes during the 2 hours following the first study drug intake
Secondary outcomes (4)
The TOTPAR15-360 which is the sum of each pain relief scale score
Measured: Measured every 15 minutes during the 2 hours following the first study drug intake at study site then every hour up to 6 hours as outpatient.
The global throat pain intensity
Measured: assessed every 15 min during 2 hours after the first study drug intake
The morning pain relief scale score
Measured: measured in morning of days 1, 2 and 3
The evening pain relief scale score
Measured: measured in evening of days 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionApr 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gilles Perdriset, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929877
- Sponsor's protocol ID
- KETOP_C_03968
- Other IDs
- 2008-008265-36(EudraCT), 2008
- Status last verified
- May 2010
- First submitted
- 29 Jun 2009
- Last updated
- 18 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double Blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of 2 Doses of Ketoprofen Lysinate Lozenges (6.25 mg & 12.5 mg) in Patients With Sore Throat
- ClinicalTrials.gov ID
- NCT00929877
- Acronym / sponsor ID
- KETOP_C_03968
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 30 Jun 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 compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120) after the first intake of study drug.
Secondary Objectives:
To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with placebo after the first intake on:
- the total pain relief summed over 15 to 360min (TOTPAR15-360)
- the changes from baseline of global throat pain intensity assessed over 15 to 120min and over 15 to 360min.
- the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min
- the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To compare pain relief, global throat pain intensity, throat soreness and swollen throat in the evening of days 1, 2 and 3
To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at follow-up visit on:
Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed by a clinical examination if needed)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketoprofen lysinate 12.5 mg | Experimental | Drug: KETOPROFEN(RP19583) |
| Ketoprofen lysinate 6.25 mg | Experimental | Drug: KETOPROFEN(RP19583) |
| Matching placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with a sore throat associated or not with an URTI > or = 24 hours and < or = 6 days' duration, in the absence of A.Streptococcus*,
- Evidence of tonsillo-pharyngitis (TPA score > or = 5) at inclusion,
- With a score of throat soreness > or = 6 (0-10 ordinal scale),
- With a perception of swollen throat > or = 60mm (VAS),
- With a global throat pain intensity such as pain at swallowing
Key exclusion criteria (16 listed)
- Patients having used any local medication containing a local oral anesthetic such as lozenge, spray, mouth rinse or any topical throat treatment within 2 hours before study entry
- Patients with positive throat swab test for A.Streptococcus pharyngitis
- Patients having used analgesics within 4 hours before study entry
- Patients having used any long-acting or slow release analgesics within 12 hours before study entry
- Patients having used any anti inflammatory treatment 8-12 hours before study entry
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(RP19583)Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days | Drug | Ketoprofen lysinate 12.5 mg |
| KETOPROFEN(RP19583)Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days | Drug | Ketoprofen lysinate 6.25 mg |
| PlaceboOral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days | Drug | Matching placebo |
Primary outcome
The TOTPAR15-120 which is the sum of each pain relief scale score
Time frame: measured every 15 minutes during the 2 hours following the first study drug intake
4 secondary outcomes
The TOTPAR15-360 which is the sum of each pain relief scale score
Time frame: Measured every 15 minutes during the 2 hours following the first study drug intake at study site then every hour up to 6 hours as outpatient.
The global throat pain intensity
Time frame: assessed every 15 min during 2 hours after the first study drug intake
The morning pain relief scale score
Time frame: measured in morning of days 1, 2 and 3
The evening pain relief scale score
Time frame: measured in evening of days 1, 2 and 3
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 18 May 2010.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Gilles Perdriset study director
Sanofi
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KETOPROFEN(RP19583) in people with Pain, run by Sanofi at 7 sites in 7 countries.
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 9 inclusion and 16 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 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Egypt, Finland, France, Germany, Mexico and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
The TOTPAR15-120 which is the sum of each pain relief scale score (time frame: measured every 15 minutes during the 2 hours following the first study drug intake). 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 18 May 2010.