Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

NCT02578186 | Completed Phase 4 Results

• 1 other identifier: 2013063
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Occasional Sleeplessness

Outcome Measures

Primary Outcomes (1)

• Mean Latency to Persistent Sleep

  Per Protocol population based on subjects who completed treatment crossover

  4 weeks

Study Arms (2)

Diphenhydramine Hydrochloride

EXPERIMENTAL

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

Drug: Diphenhydramine Hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo elixir taken when subjects had trouble falling asleep

Drug: Placebo

Interventions

Diphenhydramine Hydrochloride DRUG

30 mL at bedtime

Also known as: Zzzquil

Diphenhydramine Hydrochloride

Placebo DRUG

30 mL at bedtime

Also known as: placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Procter and Gamble: lead

MeSH Terms

Interventions

Diphenhydramine

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Andrew L. Carr, PhD
• Organization: Procter & Gamble

carr.an@pg.com

513-622-0928

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 16, 2015
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-01