Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

NCT ID: NCT02578186

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-12-31

Brief Summary

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Diphenhydramine Hydrochloride

Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep

Group Type: EXPERIMENTAL

Diphenhydramine Hydrochloride

Intervention Type: DRUG

30 mL at bedtime

Placebo

Placebo elixir taken when subjects had trouble falling asleep

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

30 mL at bedtime

Interventions

Diphenhydramine Hydrochloride

30 mL at bedtime

Intervention Type: DRUG

Placebo

30 mL at bedtime

Intervention Type: DRUG

Other Intervention Names

Zzzquil; placebo comparator

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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;
• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2013063

Identifier Type: -

Identifier Source: org_study_id