Acute PainPhase 3KSL0117NCT03836807
A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo
A Phase 3 study testing OKITASK® in people with Acute Pain, run by Dompé Farmaceutici S.p.A at 3 sites in Russia.
Trial summary
Primary objective: To assess the efficacy of OKITASK® 40 mg granules versus Placebo in patients with acute pain syndrome after removal of one molar tooth by comparing AUC0-6h of posttreatment pain profile measured by VAS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- OKITASK®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesRussia
- Study dates
- 4 Apr 2018to 21 Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed Informed Consent Form;
- Male and female, from 18 years to 65 years (inclusively);
- Subjects who undergo removal of a non-impacted molar tooth within 3 hours before randomization in the study;
- Subjects in generally good health (based upon criteria for safe administration of outpatient conscious sedation);
- Subjects requesting relief for postoperative pain within 3 h after the tooth extraction (VAS ≥30 mm);
- Subjects willing to undergo observation period for up to 9 hours after the tooth extraction;
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- Ability to complete a 100 mm VAS and a category scale during the observation period (about 9 hours);
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;
- Contraception (for females): females of child-bearing potential must be using at least one reliable method of contraception, as follows:
- hormonal oral, implantable, transdermal, or injectable contraceptives;
- a non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide; or should have:
- a male sexual partner who agrees to use a male condom with spermicide;
- a sterile sexual partner.
Who cannot join
- Subjects undergoing extraction of impacted and dystopic teeth, tooth preserving operations, apically positioning flap/vestibuloplasty with free gingival graft from the palate;
- Subjects undergoing more than one tooth extraction in the same extraction procedure;
- Subjects undergoing dental implantation simultaneously with tooth extraction;
- Allergy: ascertained or presumptive hypersensitivity to the active substances (ketoprofen and paracetamol as rescue medication) and/or formulations' ingredients; history of hypersensitivity to drugs (in particular to NSAIDs) or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
- Diseases: relevant history of renal, hepatic, cardiovascular, respiratory (including asthma), skin, haematological, endocrine, gastro-enteric and genitourinary tract or neurological and autoimmune diseases, that may interfere with the aim of the study;
- Medications: non-steroidal anti-inflammatory drugs (NSAIDS) and other analgesics [in particular ketoprofen, paracetamol and acetylsalicylic acid (ASA)], antihistamines, sedating medications, including herbal and BASs, taken 48 h before surgery;
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- Investigational drug trials: participation in the evaluation of any drug within 3 months before screening (including the last study procedure);
- Relevant history of drug and alcohol abuse.
- Positive Pregnancy test in female patients of childbearing potential (including patients in post-menopausal status for less than 2 years).
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
LLC "Centre for Interdisciplinary Dentistry and Neurology"
Moscow, 119146
Federal State Educational Institution "Moscow State Medical Dental University named after Yevdokimov "of the Russian Federation Ministry of Health
Moscow, 127473
State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev"
Yaroslavl
About this study
Official title: A Multicenter, Double Blind, Randomised, Parallel Study to Assess Efficacy and Tolerability After Single Administration of Ketoprofen Lysine Salt 40 mg Granules vs Placebo in Subjects With Acute Pain Syndrome After Removal of Molar Teeth
Primary objective:
To assess the efficacy of OKITASK® 40 mg granules versus Placebo in patients with acute pain syndrome after removal of one molar tooth by comparing AUC0-6h of posttreatment pain profile measured by VAS.
Read more
Secondary objectives:
To assess the following efficacy and safety parameters of OKITASK® 40 mg granules versus Placebo in patients with acute pain syndrome after removal of one molar tooth:
- Time profile of pain and time profile of pain relief using VAS scales
- Time to first perceptible pain relief (TFPR) and time to meaningful pain relief (TMPR)
- Proportion of patients requiring rescue medication (analgesia) and time to rescue analgesia
- Patient's overall assessment
- Rate of adverse events (AE)
Read the detailed description
This is a multicenter, double blind, randomized, parallel groups study to assess the efficacy and tolerability after single oral administration of Ketoprofen lysine salt 40 mg granules versus Placebo in male and female subjects with acute pain syndrome after removal of a molar tooth.
The patients are assigned to one of two treatment group in 1:1 ratio:
- Group 1. OKITASK® 40 mg - 35 patients;
- Group 2. Placebo - 35 patients. The study was conducted at 3 Russian sites. A total number of enrolled subjects was 70 (35 per each group). Patients' enrollment was competitive.
The study consisted of three periods: screening, study treatment and follow-up. The duration of participation of each subject in the study was to be up to 7±1 days and included: screening (up to 4 days), tooth extraction, randomization and study treatment (1 day), and follow-up (2 days).
- Conditions
- Acute Pain
- Being tested
- OKITASK®, Placebo
- Keywords
- dental pain, neuralgia
- Medical subject headings
- Acute Pain, Toothache, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKITASK®Drug
Also called ketoprofen lysine salt (KLS)
A single oral dose of OKITASK® 40 mg was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained KLS 40 mg (equivalent to 25 mg of ketoprofen). The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects.
PlaceboOther
Also called Control
A single oral dose of matching Placebo was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained Placebo. The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects.
| Study group | Role | What they receive |
|---|---|---|
| OKITASK® | Experimental | Single oral administration of Ketoprofen lysine salt 40 mg granules Receives: Drug: OKITASK® |
| Placebo | Placebo comparator | Single oral administration of placebo matching granules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the ITT Population.
The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 mm = no pain and 100 mm = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be >30 mm.
The higher the score, the worse the result.
Measured: time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment
AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the PP Population.
The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 = no pain and 100 = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be >30 mm.
The higher the score, the worse the result.
Measured: time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment
Secondary outcomes (6)
Time Profile of Pain Intensity Using VAS Scale
This outcome analyzed the evolution and the profile of pain by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain - 100 worst pain imaginable at 0' (just before taking the first medication VAS should be >30 mm) and 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240'(4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. The higher the score, the worse the result.
Measured: From time 0 (baseline value of VAS) to 6 hours post-treatment at: 0', 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration.
Time Profile of Pain Relief Using VAS Scale
This outcome analyzed the evolution of pain relief after administration of OKITASK® and after administration of Placebo, assessed by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain relief - 100 maximum relief imaginable at: 0' (just before taking the first medication VAS should be >30 mm) and 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240'(4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. The higher the score, the best the result.
Measured: From time 0 (baseline value of VAS) to 6 hours post-treatment at: 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration.
AUC5min-6h of Pain Relief Profile in the ITT and in the PP Populations
In addition, area under the curve for pain relief assessment since 5 minutes till 6 hours after the drug administration was evaluated.
Measured: from 5 min to 6 hours post-dose
Time to First Perceptible Relief (TFPR)
TFPR was measured by stopwatches, a timepiece designed to measure the amount of time that elapses between its activation and deactivation. Upon study drug administration the patients immediately started a stopwatch, once the patient felt first perceptible pain relief, the stopwatch was stopped.
The time between activation and deactivation of a stopwatch defined the outcome measure data. The shortest the time, the better the outcome.
Kaplan-Meier estimation of TFPR was expressed by median and 95% CI.
Measured: Day 1
Time to Meaningful Pain Relief (TMPR)
TMPR will be measured by stopwatches, a timepiece designed to measure the amount of time that elapses between its activation and deactivation. Upon study drug administration the patients will immediately start a stopwatch, once the patient feels meaningful perceptible pain relief, the stopwatch is stopped.
The time between activation and deactivation of a stopwatch defines the outcome measure data.
Measured: Day 1
Number of Participants With an Overall Assessment Score of "Very Good", "Satisfactory", "Poor" or "Very Poor" on a (Patient's Overall Assessment) on a 5-point Scale
The patients were asked to provide their current overall assessment answering the question "Considering all the ways that the pain affects you, how well are you doing? The patients marked the answer on the 5-point scale: 1 = very good, 2 = good, 3= satisfactory, 4 = poor, 5 = very poor.
If a patient takes rescue medication, the Patient's overall assessment will be performed after the last VAS assessment.
Measured: Day 1 at 360' or > 60' in case of early discontinuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start4 Apr 2018
- Primary completion4 Jul 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies of the same condition, open and under way.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Lanata, MD, Study director, Dompé SpA Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836807
- Sponsor's protocol ID
- KSL0117
- Acronym
- KSL0117
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2019
- Last updated
- 24 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double Blind, Randomised, Parallel Study to Assess Efficacy and Tolerability After Single Administration of Ketoprofen Lysine Salt 40 mg Granules vs Placebo in Subjects With Acute Pain Syndrome After Removal of Molar Teeth
- ClinicalTrials.gov ID
- NCT03836807
- Acronym / sponsor ID
- KSL0117 / KSL0117
- Conditions
- Acute Pain
- Keywords
- dental pain, neuralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Posted 15 Apr 2024
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 assess the efficacy of OKITASK® 40 mg granules versus Placebo in patients with acute pain syndrome after removal of one molar tooth by comparing AUC0-6h of posttreatment pain profile measured by VAS.
Secondary objectives:
To assess the following efficacy and safety parameters of OKITASK® 40 mg granules versus Placebo in patients with acute pain syndrome after removal of one molar tooth:
- Time profile of pain and time profile of pain relief using VAS scales
- Time to first perceptible pain relief (TFPR) and time to meaningful pain relief (TMPR)
- Proportion of patients requiring rescue medication (analgesia) and time to rescue analgesia
- Patient's overall assessment
- Rate of adverse events (AE)
Detailed description
This is a multicenter, double blind, randomized, parallel groups study to assess the efficacy and tolerability after single oral administration of Ketoprofen lysine salt 40 mg granules versus Placebo in male and female subjects with acute pain syndrome after removal of a molar tooth.
The patients are assigned to one of two treatment group in 1:1 ratio:
- Group 1. OKITASK® 40 mg - 35 patients;
- Group 2. Placebo - 35 patients. The study was conducted at 3 Russian sites. A total number of enrolled subjects was 70 (35 per each group). Patients' enrollment was competitive.
The study consisted of three periods: screening, study treatment and follow-up. The duration of participation of each subject in the study was to be up to 7±1 days and included: screening (up to 4 days), tooth extraction, randomization and study treatment (1 day), and follow-up (2 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OKITASK® | Experimental | Drug: OKITASK®Single oral administration of Ketoprofen lysine salt 40 mg granules |
| Placebo | Placebo comparator | Other: PlaceboSingle oral administration of placebo matching granules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed Informed Consent Form;
- Male and female, from 18 years to 65 years (inclusively);
- Subjects who undergo removal of a non-impacted molar tooth within 3 hours before randomization in the study;
- Subjects in generally good health (based upon criteria for safe administration of outpatient conscious sedation);
- Subjects requesting relief for postoperative pain within 3 h after the tooth extraction (VAS ≥30 mm);
Key exclusion criteria (9 listed)
- Subjects undergoing extraction of impacted and dystopic teeth, tooth preserving operations, apically positioning flap/vestibuloplasty with free gingival graft from the palate;
- Subjects undergoing more than one tooth extraction in the same extraction procedure;
- Subjects undergoing dental implantation simultaneously with tooth extraction;
- Allergy: ascertained or presumptive hypersensitivity to the active substances (ketoprofen and paracetamol as rescue medication) and/or formulations' ingredients; history of hypersensitivity to drugs (in particular to NSAIDs) or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
- Diseases: relevant history of renal, hepatic, cardiovascular, respiratory (including asthma), skin, haematological, endocrine, gastro-enteric and genitourinary tract or neurological and autoimmune diseases, that may interfere with the aim of 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 |
|---|---|---|
| OKITASK®Also: ketoprofen lysine salt (KLS)A single oral dose of OKITASK® 40 mg was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained KLS 40 mg (equivalent to 25 mg of ketoprofen). The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects. | Drug | OKITASK® |
| PlaceboAlso: ControlA single oral dose of matching Placebo was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained Placebo. The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects. | Other | Placebo |
Primary outcome
AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the ITT Population.
Time frame: time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment
The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 mm = no pain and 100 mm = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be >30 mm. The higher the score, the worse the result.
AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the PP Population.
Time frame: time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment
The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 = no pain and 100 = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be >30 mm. The higher the score, the worse the result.
6 secondary outcomes
Time Profile of Pain Intensity Using VAS Scale
Time frame: From time 0 (baseline value of VAS) to 6 hours post-treatment at: 0', 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration.
Time Profile of Pain Relief Using VAS Scale
Time frame: From time 0 (baseline value of VAS) to 6 hours post-treatment at: 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration.
AUC5min-6h of Pain Relief Profile in the ITT and in the PP Populations
Time frame: from 5 min to 6 hours post-dose
Time to First Perceptible Relief (TFPR)
Time frame: Day 1
Time to Meaningful Pain Relief (TMPR)
Time frame: Day 1
Number of Participants With an Overall Assessment Score of "Very Good", "Satisfactory", "Poor" or "Very Poor" on a (Patient's Overall Assessment) on a 5-point Scale
Time frame: Day 1 at 360' or > 60' in case of early discontinuation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Luigi Lanata, MD study director
Dompé SpA Milan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OKITASK® in people with Acute Pain, run by Dompé Farmaceutici S.p.A at 3 sites in Russia.
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 13 inclusion and 9 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 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the ITT Population. (time frame: time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment). 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 24 Apr 2024.