SleepPhase 4NCT01118273
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
A Phase 4 study testing Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689) and Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg in people with Sleep, run by Bayer at 1 site in United States.
Trial summary
The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Sleep
- What is being tested?
- Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689) and Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Feb 2008
- Phase
- Phase 4
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy, ambulatory, male and female volunteers between 16-45 years of age;
- Scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which must be at least a partial bony mandibular impaction;
- 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 by 2030 h +/- 15 minutes 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 antiinflammatory drugs (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;
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- Positive alcohol breathalyzer test and negative 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain
The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination
- Conditions
- Sleep
- Being tested
- Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689), Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 220 mg (BAYH6689), DPH 50mg
- Keywords
- Naproxen sodium, Diphenhydramine, Drugs, Investigational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mgDrug
Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
Naproxen Sodium 440 mg (BAYH6689)Drug
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mgDrug
One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg
Naproxen Sodium 220 mg (BAYH6689)Drug
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
DPH 50mgDrug
Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Ibuprofen 400 mg / Diphenhydramine citrate 76 mgDrug
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
| Study group | Role | What they receive |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Experimental | Not described Receives: Drug: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg |
| Naproxen Sodium 440 mg (BAYH6689) | Active comparator | Not described Receives: Drug: Naproxen Sodium 440 mg (BAYH6689) |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Experimental | Not described Receives: Drug: Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg |
| Naproxen Sodium 220 mg (BAYH6689) | Active comparator | Not described Receives: Drug: Naproxen Sodium 220 mg (BAYH6689) |
| DPH 50mg | Active comparator | Not described Receives: Drug: DPH 50mg |
| Ibuprofen 400 mg / Diphenhydramine citrate 76 mg | Active comparator | Not described Receives: Drug: Ibuprofen 400 mg / Diphenhydramine citrate 76 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time 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. In calculating the total sleep time, subjects who took rescue medication were treated as "awake" from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.
Measured: Up to 10 hours
Secondary outcomes (25)
Wake After Sleep Onset (WASO) 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. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep.
Measured: Up to 10 hours
Sleep Latency 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 was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening.
Measured: Up to 10 hours
Global Assessment of Study Medication as a Sleep-aid
Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid?
Measured: Up to 10 hours
Karolinska Sleep Diary - Sleep Quality
Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep?
Measured: Up to 10 hours
Karolinska Sleep Diary - Calmness of Sleep
Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep?
Measured: Up to 10 hours
Karolinska Sleep Diary - Easiness to Fall Asleep
Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep?
Measured: Up to 10 hours
Karolinska Sleep Diary - Premature Awakening
Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening?
Measured: Up to 10 hours
Karolinska Sleep Diary - Ease of Awakening
Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening?
Measured: Up to 10 hours
Karolinska Sleep Diary - Well Rested
Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested?
Measured: Up to 10 hours
Karolinska Sleep Diary - Sufficient Sleep
Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep?
Measured: Up to 10 hours
Total Sleep Time by Subject Assessment
Subject responded to: Please estimate the number of hours and minutes you think that you slept.
Measured: Up to 10 hours
Sleep Quality Index
Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible).
Measured: Up to 10 hours
Overall Rating of Severity in Categorical Pain Rating Scale Score
Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3).
Measured: Up to 10 hours
Change From Baseline in Categorical Pain Rating Scale Score
Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline.
Measured: Baseline and up to 10 hours
Overall Rating of Severity in Visual Analog Scale (VAS) Score
Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.
Measured: At 10 hours
Change From Baseline in Visual Analog Scale (VAS) Score
Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline.
Measured: Baseline and up to 10 hours
Overall Rating of Pain Relief
Subjects responded to question, "Overall, the relief from my starting pain was" by checking one of the following choices: 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
Subjects were allowed to "rescue" and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment.
Measured: Up to 10 hours
Cumulative Proportion of Participants Taking Rescue Medication by Hour
Subjects were allowed to "rescue" and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study.
Measured: Up to 10 hours
Global Assessment of Study Medication as a Pain Reliever
Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4)
Measured: Up to 10 hours
Number of Times Participants Took Rescue Medication
Subjects were allowed to "rescue" and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject.
Measured: Up to 10 hours
Total Wake Time 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
Activity Mean 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. Activity mean - average movement per minute.
Measured: Up to 10 hours
Wake Episode 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. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs).
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 posted6 May 2010 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionFeb 2008
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 SleepStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 162 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
- NCT01118273
- Sponsor's protocol ID
- 13053
- Status last verified
- May 2015
- First submitted
- 15 Apr 2010
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain
- ClinicalTrials.gov ID
- NCT01118273
- Acronym / sponsor ID
- 13053
- Conditions
- Sleep
- Keywords
- Naproxen sodium, Diphenhydramine, Drugs, Investigational
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 May 2010 (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 objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg | Experimental | Drug: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg |
| Naproxen Sodium 440 mg (BAYH6689) | Active comparator | Drug: Naproxen Sodium 440 mg (BAYH6689) |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg | Experimental | Drug: Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg |
| Naproxen Sodium 220 mg (BAYH6689) | Active comparator | Drug: Naproxen Sodium 220 mg (BAYH6689) |
| DPH 50mg | Active comparator | Drug: DPH 50mg |
| Ibuprofen 400 mg / Diphenhydramine citrate 76 mg | Active comparator | Drug: Ibuprofen 400 mg / Diphenhydramine citrate 76 mg |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy, ambulatory, male and female volunteers between 16-45 years of age;
- Scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which must be at least a partial bony mandibular impaction;
- 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 by 2030 h +/- 15 minutes 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 (9 listed)
- History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal antiinflammatory drugs (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 (BAYH6689) / DPH 50mgParticipants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. | Drug | Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg |
| Naproxen Sodium 440 mg (BAYH6689)Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. | Drug | Naproxen Sodium 440 mg (BAYH6689) |
| Naproxen Sodium 220 mg (BAYH6689) / DPH 50mgOne dose of naproxen sodium 220 mg plus diphenhydramine 50 mg | Drug | Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg |
| Naproxen Sodium 220 mg (BAYH6689)Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. | Drug | Naproxen Sodium 220 mg (BAYH6689) |
| DPH 50mgParticipants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally. | Drug | DPH 50mg |
| Ibuprofen 400 mg / Diphenhydramine citrate 76 mgParticipants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally. | Drug | Ibuprofen 400 mg / Diphenhydramine citrate 76 mg |
Primary outcome
Total Sleep Time Measured by Actigraphy
Time frame: Up to 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. In calculating the total sleep time, subjects who took rescue medication were treated as "awake" from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.
25 secondary outcomes
Wake After Sleep Onset (WASO) Measured by Actigraphy
Time frame: Up to 10 hours
Sleep Latency Measured by Actigraphy
Time frame: Up to 10 hours
Global Assessment of Study Medication 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
Total Sleep Time by Subject Assessment
Time frame: Up to 10 hours
Sleep Quality Index
Time frame: Up to 10 hours
Overall Rating of Severity in Categorical Pain Rating Scale Score
Time frame: Up to 10 hours
Change From Baseline in Categorical Pain Rating Scale Score
Time frame: Baseline and up to 10 hours
Overall Rating of Severity in Visual Analog Scale (VAS) Score
Time frame: At 10 hours
Change From Baseline in Visual Analog Scale (VAS) Score
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 Participants Taking Rescue Medication by Hour
Time frame: Up to 10 hours
Global Assessment of Study Medication as a Pain Reliever
Time frame: Up to 10 hours
Number of Times Participants Took Rescue Medication
Time frame: Up to 10 hours
Total Wake Time Measured by Actigraphy
Time frame: Up to 10 hours
Sleep Efficiency Measured by Actigraphy
Time frame: Up to 10 hours
Activity Mean Measured by Actigraphy
Time frame: Up to 10 hours
Wake Episode Measured by Actigraphy
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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689) and Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg in people with Sleep, 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 5 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 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Total Sleep Time Measured by Actigraphy (time frame: Up to 10 hours). 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 8 Jun 2015.