Pain, PostoperativePhase 3Morpheus IINCT01280591
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
A Phase 3 study testing Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) and Naproxen sodium 440 mg (BAYH6689) in people with Pain, Postoperative, run by Bayer at 2 sites in United States.
Trial summary
The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with… Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) and Naproxen sodium 440 mg (BAYH6689)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 712 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Feb 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy, ambulatory, male and female volunteers ages 12 and older
- Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:
- one full bony impaction
- two partial bony impactions
- one full bony impaction and one partial bony impaction
- one full bony impaction and one soft tissue impaction
Show all 10Show fewer
- one full bony impaction and one erupted third molar. Two full bony mandibular impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.
- Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of ≥ 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery
- 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, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
- Provide a personally signed and dated informed consent 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, diphenhydramine, nonsteroidal anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the 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 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
- Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months
Show all 10Show fewer
- Positive alcohol breathalyzer test and positive urine drug test prior to surgery
- Females who are pregnant or lactating
- Chronic or severe sleep problems that do not respond to / Over the Counter (OTC) medication and requires a prescription hypnotic or sedative
- Habitually spends less than 6.5 hours in bed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Austin, Texas, 78744
Study site
Salt Lake City, Utah, 84124
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep
The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.
- Conditions
- Pain, Postoperative
- Being tested
- Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 440 mg (BAYH6689), DPH 50 mg
- Keywords
- Naproxen sodium, Diphenhydramine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)Drug
Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)Drug
Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
Naproxen sodium 440 mg (BAYH6689)Drug
Participants received two Naproxen sodium 220 mg tablets orally, single dose
DPH 50 mgDrug
Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
| Study group | Role | What they receive |
|---|---|---|
| Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) | Experimental | Not described Receives: Drug: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) |
| Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) | Experimental | Not described Receives: Drug: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) |
| Naproxen sodium 440 mg (BAYH6689) | Active comparator | Not described Receives: Drug: Naproxen sodium 440 mg (BAYH6689) |
| DPH 50 mg | Active comparator | Not described Receives: Drug: DPH 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wake Time After Sleep Onset (WASO) Measured by Actigraphy
WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Measured: Up to 10 hours
Sleep Latency Measured by Actigraphy
Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Measured: Up to 10 hours
Secondary outcomes (19)
Total Sleep Time Measured by Actigraphy
Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Measured: Up to 10 hours
Sleep Efficiency Measured by Actigraphy
Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Measured: Up to 10 hours
Global Assessment of Investigational Product as a Sleep Aid
The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).
Measured: Up to 10 hours
Karolinska Sleep Diary - Sleep Quality
Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)
Measured: Up to 10 hours
Karolinska Sleep Diary - Calmness of Sleep
Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)
Measured: Up to 10 hours
Karolinska Sleep Diary - Easiness to Fall Asleep
Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)
Measured: Up to 10 hours
Karolinska Sleep Diary - Premature Awakening
Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)
Measured: Up to 10 hours
Karolinska Sleep Diary - Ease of Awakening
Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)
Measured: Up to 10 hours
Karolinska Sleep Diary - Well Rested
Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)
Measured: Up to 10 hours
Karolinska Sleep Diary - Sufficient Sleep
Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)
Measured: Up to 10 hours
Subjective Sleep Questionnaire - Quality of Your Sleep Last Night
Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent)
Measured: Up to 10 hours
Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night
Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)
Measured: Up to 10 hours
Subjective Sleep Questionnaire - Time to Fall Asleep Last Night
Subjects responded to Estimate of how long it took to fall asleep (minutes)
Measured: Up to 10 hours
Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed
Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)
Measured: Up to 10 hours
Change From Baseline in Pain Intensity
Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain
Measured: Baseline and up to 10 hours
Overall Rating of Pain Relief
The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement "Overall, the relief from my starting pain was": no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4).
Measured: Up to 10 hours
Time to Rescue Medication
If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded
Measured: Up to 10 hours
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded
Measured: Up to 10 hours
Global Assessment of Investigational Product as a Pain Reliever
The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).
Measured: Up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionFeb 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
- 712 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
- NCT01280591
- Sponsor's protocol ID
- 14837
- Acronym
- Morpheus II
- Status last verified
- May 2015
- First submitted
- 20 Jan 2011
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cooper S, Laurora I, Wang Y, Venkataraman P, An R, Roth T. Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia. Int J Clin Pract. 2015 Oct;69(10):1149-58. doi: 10.1111/ijcp.12669. Epub 2015 May 21.
PubMed 25996289
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep
- ClinicalTrials.gov ID
- NCT01280591
- Acronym / sponsor ID
- Morpheus II / 14837
- Conditions
- Pain, Postoperative
- Keywords
- Naproxen sodium, Diphenhydramine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Posted 17 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) | Experimental | Drug: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) |
| Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) | Experimental | Drug: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) |
| Naproxen sodium 440 mg (BAYH6689) | Active comparator | Drug: Naproxen sodium 440 mg (BAYH6689) |
| DPH 50 mg | Active comparator | Drug: DPH 50 mg |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Healthy, ambulatory, male and female volunteers ages 12 and older
- Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:
- Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of ≥ 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery
- 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, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
- Provide a personally signed and dated informed consent 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).
Key exclusion criteria (10 listed)
- History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the 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 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 440 mg / DPH 50 mg (BAY98-7111)Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose | Drug | Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) |
| Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose | Drug | Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) |
| Naproxen sodium 440 mg (BAYH6689)Participants received two Naproxen sodium 220 mg tablets orally, single dose | Drug | Naproxen sodium 440 mg (BAYH6689) |
| DPH 50 mgParticipants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose | Drug | DPH 50 mg |
Primary outcome
Wake Time After Sleep Onset (WASO) Measured by Actigraphy
Time frame: Up to 10 hours
WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Sleep Latency Measured by Actigraphy
Time frame: Up to 10 hours
Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
19 secondary outcomes
Total Sleep Time Measured by Actigraphy
Time frame: Up to 10 hours
Sleep Efficiency Measured by Actigraphy
Time frame: Up to 10 hours
Global Assessment of Investigational Product as a Sleep Aid
Time frame: Up to 10 hours
Karolinska Sleep Diary - Sleep Quality
Time frame: Up to 10 hours
Karolinska Sleep Diary - Calmness of Sleep
Time frame: Up to 10 hours
Karolinska Sleep Diary - Easiness to Fall Asleep
Time frame: Up to 10 hours
Karolinska Sleep Diary - Premature Awakening
Time frame: Up to 10 hours
Karolinska Sleep Diary - Ease of Awakening
Time frame: Up to 10 hours
Karolinska Sleep Diary - Well Rested
Time frame: Up to 10 hours
Karolinska Sleep Diary - Sufficient Sleep
Time frame: Up to 10 hours
Subjective Sleep Questionnaire - Quality of Your Sleep Last Night
Time frame: Up to 10 hours
Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night
Time frame: Up to 10 hours
Subjective Sleep Questionnaire - Time to Fall Asleep Last Night
Time frame: Up to 10 hours
Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed
Time frame: Up to 10 hours
Change From Baseline in Pain Intensity
Time frame: Baseline and up to 10 hours
Overall Rating of Pain Relief
Time frame: Up to 10 hours
Time to Rescue Medication
Time frame: Up to 10 hours
Cumulative Proportion of Subjects Taking Rescue Medication by Hour
Time frame: Up to 10 hours
Global Assessment of Investigational Product as a Pain Reliever
Time frame: Up to 10 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25996289Cooper S, Laurora I, Wang Y, Venkataraman P, An R, Roth T. Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia. Int J Clin Pract. 2015 Oct;69(10):1149-58. doi: 10.1111/ijcp.12669. Epub 2015 May 21.
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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.
Bayer Study Director study director
Bayer
2 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 Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) and Naproxen sodium 440 mg (BAYH6689) in people with Pain, Postoperative, run by Bayer at 2 sites 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 10 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 17 Jun 2014). 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?
Wake Time After Sleep Onset (WASO) Measured by Actigraphy (time frame: Up to 10 hours). 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?
On the ClinicalTrials.gov record for NCT01280591, 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 8 Jun 2015.