Trial Outcomes & Findings for Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness (NCT NCT02578186)
NCT ID: NCT02578186
Last Updated: 2017-03-15
Results Overview
Per Protocol population based on subjects who completed treatment crossover
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
4 weeks
Results posted on
2017-03-15
Participant Flow
Participants were recruited at Henry Ford Medical Hospital, Detroit MI, USA between October 2013 to December 2014.
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.
Participant milestones
| Measure |
Diphenhydramine Hydrochloride, Then Placebo
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, Then Diphenhydramine Hydrochloride
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 1 (First of Crossover)
STARTED
|
17
|
18
|
|
Period 1 (First of Crossover)
COMPLETED
|
12
|
13
|
|
Period 1 (First of Crossover)
NOT COMPLETED
|
5
|
5
|
|
Period 2 (Second of Crossover)
STARTED
|
12
|
13
|
|
Period 2 (Second of Crossover)
COMPLETED
|
12
|
13
|
|
Period 2 (Second of Crossover)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Diphenhydramine Hydrochloride, Then Placebo
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, Then Diphenhydramine Hydrochloride
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 1 (First of Crossover)
Did not meet Phase 2 eligibility
|
4
|
4
|
|
Period 1 (First of Crossover)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=33 Participants
Entire Study Population Includes groups that received Placebo and Drug First
|
|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight
|
163.3 lb
STANDARD_DEVIATION 34.29 • n=5 Participants
|
|
Height
|
66.4 inches
STANDARD_DEVIATION 3.00 • n=5 Participants
|
|
Body Mass Index (BMI)
|
25.9 kg/m2
STANDARD_DEVIATION 4.81 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 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.
Per Protocol population based on subjects who completed treatment crossover
Outcome measures
| Measure |
Diphenhydramine Hydrochloride
n=22 Participants
Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep
Diphenhydramine Hydrochloride: 30 mL at bedtime
|
Placebo
n=22 Participants
Placebo elixir taken when subjects had trouble falling asleep
Placebo: 30 mL at bedtime
|
|---|---|---|
|
Mean Latency to Persistent Sleep
|
19.1 minutes
Standard Error 3.1
|
27.1 minutes
Standard Error 3.1
|
Adverse Events
Diphenhydramine Hydrochloride
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diphenhydramine Hydrochloride
n=30 participants at risk
Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep
Diphenhydramine Hydrochloride: 30 mL at bedtime
|
Placebo
n=29 participants at risk
Placebo elixir taken when subjects had trouble falling asleep
Placebo: 30 mL at bedtime
|
|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/29 • 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.
|
|
General disorders
Fatigue
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/29 • 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.
|
|
General disorders
Product Taste Abnormal
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/29 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/30 • 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.
|
3.4%
1/29 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/29 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/30 • 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.
|
6.9%
2/29 • Number of events 2 • 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.
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Number of events 4 • 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.
|
13.8%
4/29 • Number of events 4 • 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.
|
|
Nervous system disorders
Migraine
|
3.3%
1/30 • Number of events 1 • 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.
|
3.4%
1/29 • Number of events 1 • 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.
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/29 • 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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/29 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/29 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/29 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60