Pain, PostoperativePhase 3VERNENCT01389284
Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
A Phase 3 study testing Naproxen Sodium ER (BAYH6689) and Naproxen Sodium IR (Aleve, BAYH6689) in people with Pain, Postoperative, run by Bayer at 1 site in United States.
Trial summary
The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Naproxen Sodium ER (BAYH6689) and Naproxen Sodium IR (Aleve, BAYH6689)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2011
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy, ambulatory, male and female volunteers 15 years of age and above
- Scheduled to undergo surgical removal of up to two impacted third molars, one of which must be mandibular full or partial bony impaction and the other a maxillary impaction
- Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery
- Have not taken any form of medication or herbal supplements (ie, St. Johns Wort) within 5 days of admission (except for oral contraceptives, prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication (other than that provided to them) throughout the study
- Have not consumed alcoholic beverages, or foods and beverages containing xanthines (examples, coffee, tea, chocolate, and colas) after midnight prior to surgery and agree not to consume any of these foods or beverages throughout the evaluation period
- Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine) preoperatively, with or without vasoconstrictor and nitrous oxide
Show all 10Show fewer
- Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of ≥ 50 mm on the 100 mm Visual Analog Scale (VAS) within 4 hours postsurgery, but no later than 1330 hours +/- 15 minutes
- Understand the pain rating scales (as judged by the study coordinator)
- Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
- Provide a personally signed and dated informed consent form (ICF) indicating that the subject has been informed of all pertinent aspects of the trial, (subjects < 18 years of age must sign a written assent and have parental or guardian consent)
Who cannot join
- History of hypersensitivity to naproxen sodium, acetaminophen, Non Steroidal Anti-inflammatory Drugs (NSAIDS), aspirin, hydrocodone, similar pharmacological agents or components of the investigational products
- Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years
- Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator
- Current or past history of gastrointestinal bleeding or other bleeding disorder(s)
- Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator
- Use of any Over-the-Counter (OTC) or prescription medications with which the administration of naproxen, acetaminophen, ibuprofen or any other NSAIDs, Lortab, is contraindicated or use of any medications within 5 days of surgery (except oral contraceptives, prophylactic antibiotics or medications to treat benign conditions such as antibiotics to treat acne)
Show all 11Show fewer
- Females who are pregnant or lactating
- Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week for greater than 3 weeks)
- Alcoholism or drug abuse within 2 years prior to the Screening Visit or routine consumption of 3 or more alcohol containing beverages per day
- Positive urine, alcohol or nicotine test on day of surgery
- Smokers or using nicotine replacement therapies including transdermal patches, spray, lozenges or gum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Analgesic Efficacy and Safety of Extended Release Naproxen Sodium Tablets in Postsurgical Dental Pain
The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.
- Conditions
- Pain, Postoperative
- Being tested
- Naproxen Sodium ER (BAYH6689), Naproxen Sodium IR (Aleve, BAYH6689), Naproxen Sodium ER Placebo, Naproxen Sodium IR Placebo
- Keywords
- Naproxen Sodium,, dental pain
- Medical subject headings
- Pain, Postoperative, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen Sodium ER (BAYH6689)Drug
660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours
Naproxen Sodium IR (Aleve, BAYH6689)Drug
220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours
Naproxen Sodium ER PlaceboDrug
Matching placebo of 660 mg Naproxen Sodium ER for 24 hours
Naproxen Sodium IR PlaceboDrug
Matching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Experimental | 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) Receives: Drug: Naproxen Sodium ER (BAYH6689); Drug: Naproxen Sodium IR Placebo |
| Naproxen Sodium IR (Aleve, BAYH6689) | Active comparator | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min) Receives: Drug: Naproxen Sodium IR (Aleve, BAYH6689); Drug: Naproxen Sodium ER Placebo |
| Placebo | Placebo comparator | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) Receives: Drug: Naproxen Sodium ER Placebo; Drug: Naproxen Sodium IR Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)
SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.
Measured: From 0 to 24 hours post-dose
Secondary outcomes (8)
Summed, Time-weighted Pain Intensity Differences (SPID)
Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.
Measured: 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose
Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24.
Measured: 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose
Pain Intensity Differences (PIDs) by Time From Initial Dose
Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe
Measured: At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
Pain Relief From Initial Dose
Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief
Measured: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
Median Time to First Intake of Rescue Medication
Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group.
Measured: Up to 24 hours postdose
Cumulative Percentage of Participants Who Took Rescue Medication
Measured: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
Number of Times the Participants Took Rescue Medication Over the 24-hour Period
Measured: 24 hours postdose
Global Assessment of the Investigational Product as a Pain Reliever
Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent
Measured: 24 hours postdose or immediately before the first intake of rescue medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389284
- Sponsor's protocol ID
- 15142
- Other IDs
- 2014-005272-28, 2014
- Acronym
- VERNE
- Status last verified
- Aug 2015
- First submitted
- 6 Jul 2011
- Last updated
- 25 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Laurora I, An R. Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials. Curr Med Res Opin. 2016;32(2):331-42. doi: 10.1185/03007995.2015.1123680. Epub 2015 Dec 15.
PubMed 26588111
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Analgesic Efficacy and Safety of Extended Release Naproxen Sodium Tablets in Postsurgical Dental Pain
- ClinicalTrials.gov ID
- NCT01389284
- Acronym / sponsor ID
- VERNE / 15142
- Conditions
- Pain, Postoperative
- Keywords
- Naproxen Sodium,, dental pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Posted 7 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Experimental | Drug: Naproxen Sodium ER (BAYH6689), Drug: Naproxen Sodium IR Placebo1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
| Naproxen Sodium IR (Aleve, BAYH6689) | Active comparator | Drug: Naproxen Sodium IR (Aleve, BAYH6689), Drug: Naproxen Sodium ER Placebo1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min) |
| Placebo | Placebo comparator | Drug: Naproxen Sodium ER Placebo, Drug: Naproxen Sodium IR Placebo1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy, ambulatory, male and female volunteers 15 years of age and above
- Scheduled to undergo surgical removal of up to two impacted third molars, one of which must be mandibular full or partial bony impaction and the other a maxillary impaction
- Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery
- Have not taken any form of medication or herbal supplements (ie, St. Johns Wort) within 5 days of admission (except for oral contraceptives, prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication (other than that provided to them) throughout the study
- Have not consumed alcoholic beverages, or foods and beverages containing xanthines (examples, coffee, tea, chocolate, and colas) after midnight prior to surgery and agree not to consume any of these foods or beverages throughout the evaluation period
Key exclusion criteria (11 listed)
- History of hypersensitivity to naproxen sodium, acetaminophen, Non Steroidal Anti-inflammatory Drugs (NSAIDS), aspirin, hydrocodone, similar pharmacological agents or components of the investigational products
- Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years
- Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator
- Current or past history of gastrointestinal bleeding or other bleeding disorder(s)
- Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator
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 |
|---|---|---|
| Naproxen Sodium ER (BAYH6689)660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours | Drug | Naproxen Sodium ER (BAYH6689) |
| Naproxen Sodium IR (Aleve, BAYH6689)220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours | Drug | Naproxen Sodium IR (Aleve, BAYH6689) |
| Naproxen Sodium ER PlaceboMatching placebo of 660 mg Naproxen Sodium ER for 24 hours | Drug | Naproxen Sodium IR (Aleve, BAYH6689), Placebo |
| Naproxen Sodium IR PlaceboMatching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours | Drug | Naproxen Sodium ER (BAYH6689), Placebo |
Primary outcome
Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)
Time frame: From 0 to 24 hours post-dose
SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.
8 secondary outcomes
Summed, Time-weighted Pain Intensity Differences (SPID)
Time frame: 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose
Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
Time frame: 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose
Pain Intensity Differences (PIDs) by Time From Initial Dose
Time frame: At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
Pain Relief From Initial Dose
Time frame: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
Median Time to First Intake of Rescue Medication
Time frame: Up to 24 hours postdose
Cumulative Percentage of Participants Who Took Rescue Medication
Time frame: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
Number of Times the Participants Took Rescue Medication Over the 24-hour Period
Time frame: 24 hours postdose
Global Assessment of the Investigational Product as a Pain Reliever
Time frame: 24 hours postdose or immediately before the first intake of rescue medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26588111Laurora I, An R. Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials. Curr Med Res Opin. 2016;32(2):331-42. doi: 10.1185/03007995.2015.1123680. Epub 2015 Dec 15.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Bayer Study Director study director
Bayer
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 Naproxen Sodium ER (BAYH6689) and Naproxen Sodium IR (Aleve, BAYH6689) in people with Pain, Postoperative, run by Bayer at 1 site in United States.
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 11 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 Aug 2015. 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 United States. 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 7 May 2013). 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?
Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) (time frame: From 0 to 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389284, which also lists 1 linked publication.
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 Aug 2015.