Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Procter and Gamble
• Treatments: Diphenhydramine; Promethazine

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;