check_circleStudy Completed
Pain, postoperative
Bayer Identifier:infoA unique number for a trial given by Bayer.
15881
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
Evaluate analgesic / sedative efficacy of Naproxen sodium and diphenhydramine in patients with Postsurgical Dental Pain
Trial purpose
The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.
Key Participants Requirements
Sex
BothAge
12 - N/ATrial summary
Enrollment Goal info
267The overall number of participants needed for a trial.
Trial Dates info
December 2011 - February 2012Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 3A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Aleve PM (BAY98-7111)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
YesA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
Status | Institution | Location |
---|---|---|
Completed | Pharmaceutical Product Development, LLC | Austin, 78744, United States |
Completed | Lifetree Clinical Research | Salt Lake City, 84106, United States |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Wake time after sleep onset (WASO) measured by actigraphydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Sleep latency measured by actigraphydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Total sleep time measured by actigraphydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Sleep efficiency measured by actigraphydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Global assessment of investigational product as a sleep aiddate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - sleep qualitydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - calmness of sleepdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - easiness to fall asleepdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - premature awakeningdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - ease of awakeningdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - well resteddate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - sufficient sleepdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Subjective sleep questionnaire - quality of your sleep last nightdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Subjective sleep questionnaire - refreshing nature of your sleep last nightdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Subjective sleep questionnaire - time to fall asleep last nightdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- 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 beddate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Change from baseline in pain intensitydate_rangeTime Frame:Baseline and up to 10 hoursenhanced_encryptionNoSafety Issue:
- Overall rating of pain reliefdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Time to rescue medicationdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Cumulative proportion of participants taking rescue medication by hourdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Global assessment of investigational product as a pain relieverdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Double Blind“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
3A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.