Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

• ClinicalTrials.gov Identifier: NCT02578186
• Recruitment Status: Completed
• First Posted: October 16, 2015
• Results First Posted: March 15, 2017
• Last Update Posted: March 15, 2017
• Sponsor: Procter and Gamble
• Information provided by (Responsible Party): Procter and Gamble

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Occasional Sleeplessness	Drug: Diphenhydramine Hydrochloride; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blind, Placebo-Controlled, Crossover, In-home Study to Assess the Efficacy of Diphenhydramine Hydrochloride in Subjects With Occasional Sleeplessness
• Study Start Date: November 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Diphenhydramine Hydrochloride; Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep	Drug: Diphenhydramine Hydrochloride; 30 mL at bedtime; Other Name: Zzzquil
Placebo Comparator: Placebo; Placebo elixir taken when subjects had trouble falling asleep	Drug: Placebo; 30 mL at bedtime; Other Name: placebo comparator

Outcome Measures

Primary Outcome Measures :

1. Mean Latency to Persistent Sleep [ Time Frame: 4 weeks ]
   Per Protocol population based on subjects who completed treatment crossover

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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;

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT02578186
• Other Study ID Numbers: 2013063
• First Posted: October 16, 2015
• Results First Posted: March 15, 2017
• Last Update Posted: March 15, 2017
• Last Verified: January 2017

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Diphenhydramine; Promethazine; Sleep Aids, Pharmaceutical; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Local; Anesthetics; Sensory System Agents; Peripheral Nervous System Agents; Antiemetics; Autonomic Agents; Gastrointestinal Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Antipruritics; Dermatologic Agents