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Trial record 2 of 450 for:    diphenhydramine

Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

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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:
Information provided by (Responsible Party):
Procter and Gamble

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE October 16, 2015
Results First Submitted Date  ICMJE August 30, 2016
Results First Posted Date  ICMJE March 15, 2017
Last Update Posted Date March 15, 2017
Study Start Date  ICMJE November 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Mean Latency to Persistent Sleep [ Time Frame: 4 weeks ]
Per Protocol population based on subjects who completed treatment crossover
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
Mean Latency to Persistent Sleep [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT02578186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness
Official Title  ICMJE Randomized, Double-Blind, Placebo-Controlled, Crossover, In-home Study to Assess the Efficacy of Diphenhydramine Hydrochloride in Subjects With Occasional Sleeplessness
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Occasional Sleeplessness
Intervention  ICMJE
  • Drug: Diphenhydramine Hydrochloride
    30 mL at bedtime
    Other Name: Zzzquil
  • Drug: Placebo
    30 mL at bedtime
    Other Name: placebo comparator
Study Arms  ICMJE
  • Experimental: Diphenhydramine Hydrochloride
    Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep
    Intervention: Drug: Diphenhydramine Hydrochloride
  • Placebo Comparator: Placebo
    Placebo elixir taken when subjects had trouble falling asleep
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2015)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02578186
Other Study ID Numbers  ICMJE 2013063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Procter and Gamble
Study Sponsor  ICMJE Procter and Gamble
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Procter and Gamble
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP