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Trial record 2 of 448 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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Occasional Sleeplessness
Interventions Drug: Diphenhydramine Hydrochloride
Drug: Placebo
Enrollment 33
Recruitment Details Participants were recruited at Henry Ford Medical Hospital, Detroit MI, USA between October 2013 to December 2014.
Pre-assignment Details 43 subjects screened. 33 subjects received product (ie, enrolled, for the purposes of this reporting), of whom 2 withdrew but re-enrolled (per protocol amendment). These 2 subjects are counted as starting each sequence in the table below, bringing total started to 35 and for AEs to 30 and 29 (DPH and placebo, respectively.) 25 subjects completed.
Arm/Group Title Diphenhydramine Hydrochloride, Then Placebo Placebo, Then Diphenhydramine Hydrochloride
Hide Arm/Group Description

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

Diphenhydramine Hydrochloride: DPH (50 mg) once a day at bedtime in first intervention period and Placebo once a day at bedtime for the second intervention period (after 5 day washout period).

Placebo elixir taken when subjects had trouble falling asleep

Placebo: Placebo once a day at bedtime in first intervention period and DPH (50 mg) once a day at bedtime for the second intervention period (after 5 day washout period).

Period Title: Period 1 (First of Crossover)
Started [1] 17 18
Completed 12 13
Not Completed 5 5
Reason Not Completed
Did not meet Phase 2 eligibility             4             4
Withdrawal by Subject             1             1
[1]
2 re-enrolled subjects have a count in each sequence in Started Row and a corresponding disposition.
Period Title: Period 2 (Second of Crossover)
Started 12 13
Completed 12 13
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Entire Study Population Includes groups that received Placebo and Drug First
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
36.2  (9.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
25
  75.8%
Male
8
  24.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Hispanic or Latino
1
   3.0%
Not Hispanic or Latino
32
  97.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   6.1%
Native Hawaiian or Other Pacific Islander
1
   3.0%
Black or African American
12
  36.4%
White
17
  51.5%
More than one race
1
   3.0%
Unknown or Not Reported
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Lb
Number Analyzed 33 participants
163.3  (34.29)
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 33 participants
66.4  (3.00)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 33 participants
25.9  (4.81)
1.Primary Outcome
Title Mean Latency to Persistent Sleep
Hide Description Per Protocol population based on subjects who completed treatment crossover
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with evaluable data for mean latency to persistent sleep for both treatment periods were included in the efficacy analysis provided they meet the other defined Per Protocol criteria. All data for each treatment and endpoint were averaged for all days in which the study medication was taken in a given treatment period.
Arm/Group Title Diphenhydramine Hydrochloride Placebo
Hide Arm/Group Description:

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

Diphenhydramine Hydrochloride: 30 mL at bedtime

Placebo elixir taken when subjects had trouble falling asleep

Placebo: 30 mL at bedtime

Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: minutes
19.1  (3.1) 27.1  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diphenhydramine Hydrochloride, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0312
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame After informed consent but prior to 1st dose of study drug, only SAEs were collected in the eCRFs (the study had no SAEs). After a patient received his/her first dose of investigational product until his/her exit from the study, all AEs were collected.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diphenhydramine Hydrochloride Placebo
Hide Arm/Group Description

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

Diphenhydramine Hydrochloride: 30 mL at bedtime

Placebo elixir taken when subjects had trouble falling asleep

Placebo: 30 mL at bedtime

All-Cause Mortality
Diphenhydramine Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Diphenhydramine Hydrochloride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diphenhydramine Hydrochloride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/30 (26.67%)      7/29 (24.14%)    
Gastrointestinal disorders     
Dry Mouth * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
General disorders     
Fatigue * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Product Taste Abnormal * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Infections and infestations     
Nasopharyngitis * 1  0/30 (0.00%)  0 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Back Pain * 1  0/30 (0.00%)  0 2/29 (6.90%)  2
Nervous system disorders     
Headache * 1  3/30 (10.00%)  4 4/29 (13.79%)  4
Migraine * 1  1/30 (3.33%)  1 1/29 (3.45%)  1
Somnolence * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Reproductive system and breast disorders     
Dysmenorrhoea * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Oropharyngeal Pain * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Andrew L. Carr, PhD
Organization: Procter & Gamble
Phone: 513-622-0928
Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT02578186     History of Changes
Other Study ID Numbers: 2013063
First Submitted: October 14, 2015
First Posted: October 16, 2015
Results First Submitted: August 30, 2016
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017