Occasional SleeplessnessPhase 4NCT02578186

Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

A Phase 4 study testing Diphenhydramine Hydrochloride in people with Occasional Sleeplessness, run by Procter and Gamble.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Occasional Sleeplessness
What is being tested?: Diphenhydramine Hydrochloride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: No sites listed yet
Study dates: Nov 2013to Dec 2014
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

be male or female subjects, ≥18 years of age to 55 years of age, who report that they are currently experiencing occasional sleeplessness characterized by difficulty initiating sleep (ie, taking ≥30 minutes to fall asleep) on average 2-4 times per week for less than 1 month;
be in good general health without clinically significant disease (no previously diagnosed sleep disorders);
if female, have a negative screening pregnancy test and agree to be on approved methods of birth control throughout the study

Who cannot join

have a clinically significant illness within 30 days of Screening;
are taking medication that could interfere with the study medication;
have been under a clinician's care for insomnia treatment and control within the past year or has a history of insomnia or is currently taking prescription medications for insomnia;
are currently taking medications known to effect sleep function;
have current or past history of serious, severe or unstable physical or psychiatric illness;
have current diagnosis of severe urinary retention;

Show all 9Show fewer

have current diagnosis of untreated narrow angle glaucoma;
had participated in a clinical drug study or used an investigational new drug during the previous 30 days;
have any clinically significant or abnormal finding in physical examination, vital signs, ECG, or clinical laboratory tests that may affect the subject's safety or outcome of the study;

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Crossover, In-home Study to Assess the Efficacy of Diphenhydramine Hydrochloride in Subjects With Occasional Sleeplessness

The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.

Read the detailed description

Diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of the ethanolamine classes with known sleep-inducing properties and is approved by the Food \& Drug Administration to reduce the time to sleep onset in individuals having difficulty falling asleep. The goal of the study is to investigate diphenhydramine versus placebo with regard to several sleep parameters, including time to sleep onset, in healthy adult subjects suffering from occasional sleeplessness.

Conditions: Occasional Sleeplessness
Being tested: Diphenhydramine Hydrochloride, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diphenhydramine HydrochlorideDrug
Also called Zzzquil
30 mL at bedtime
PlaceboDrug
Also called placebo comparator
30 mL at bedtime

Study groups in NCT02578186
Study group	Role	What they receive
Diphenhydramine Hydrochloride	Experimental	Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep Receives: Drug: Diphenhydramine Hydrochloride
Placebo	Placebo comparator	Placebo elixir taken when subjects had trouble falling asleep Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Latency to Persistent Sleep
Per Protocol population based on subjects who completed treatment crossover
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Dec 2014

First posted16 Oct 2015 (estimated)
Study startNov 2013
Primary completionDec 2014
Study completionDec 2014

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 Occasional SleeplessnessStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02578186
Sponsor's protocol ID: 2013063
Status last verified: Jan 2017
First submitted: 14 Oct 2015
Last updated: 15 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo-Controlled, Crossover, In-home Study to Assess the Efficacy of Diphenhydramine Hydrochloride in Subjects With Occasional Sleeplessness
ClinicalTrials.gov ID: NCT02578186
Acronym / sponsor ID: 2013063
Conditions: Occasional Sleeplessness
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Procter and GambleIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 16 Oct 2015 (estimated)
Results: Posted 15 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Diphenhydramine Hydrochloride	Experimental	Drug: Diphenhydramine HydrochlorideDiphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep
Placebo	Placebo comparator	Drug: PlaceboPlacebo elixir taken when subjects had trouble falling asleep

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

be male or female subjects, ≥18 years of age to 55 years of age, who report that they are currently experiencing occasional sleeplessness characterized by difficulty initiating sleep (ie, taking ≥30 minutes to fall asleep) on average 2-4 times per week for less than 1 month;
be in good general health without clinically significant disease (no previously diagnosed sleep disorders);
if female, have a negative screening pregnancy test and agree to be on approved methods of birth control throughout the study

Key exclusion criteria (9 listed)

have a clinically significant illness within 30 days of Screening;
are taking medication that could interfere with the study medication;
have been under a clinician's care for insomnia treatment and control within the past year or has a history of insomnia or is currently taking prescription medications for insomnia;
are currently taking medications known to effect sleep function;
have current or past history of serious, severe or unstable physical or psychiatric illness;

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
Diphenhydramine HydrochlorideAlso: Zzzquil30 mL at bedtime	Drug	Diphenhydramine Hydrochloride
PlaceboAlso: placebo comparator30 mL at bedtime	Drug	Placebo

Primary outcome

Mean Latency to Persistent Sleep
Time frame: 4 weeks
Per Protocol population based on subjects who completed treatment crossover

Results and safety

Results posted to the registry on 15 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diphenhydramine Hydrochloride, Then Placebo	17	12
Placebo, Then Diphenhydramine Hydrochloride	18	13

Primary outcome: Mean Latency to Persistent Sleep

Time frame: 4 weeks. Mean (Standard Error). Unit: minutes

Measure	Diphenhydramine Hydrochloride n = 22	Placebo n = 22
Value	19.1 (3.1)	27.1 (3.1)

Diphenhydramine Hydrochloride vs Placebo: p = 0.0312, ANCOVA

Population analysed: Subjects with evaluable data for mean latency to persistent sleep for both treatment periods were included in the efficacy analysis provided they meet the other defined Per Protocol criteria. All data for each treatment and endpoint were averaged for all days in which the study medication was taken in a given treatment period.

Adverse events

Time frame: After informed consent but prior to 1st dose of study drug, only SAEs were collected in the eCRFs (the study had no SAEs). After a patient received his/her first dose of investigational product until his/her exit from the study, all AEs were collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diphenhydramine Hydrochloride	0 of 30 (0%)	8 of 30 (26.7%)	Not reported
Placebo	0 of 29 (0%)	7 of 29 (24.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diphenhydramine Hydrochloride in people with Occasional Sleeplessness, run by Procter and Gamble.

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 3 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 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

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 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 15 Mar 2017). 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?

Mean Latency to Persistent Sleep (time frame: 4 weeks). 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 NCT02578186.

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 15 Mar 2017.