SM-1 vs. an Active Comparator in A Model of Transient Insomnia (NCT04396327) | Clinical Trial Compass
Not Yet RecruitingPhase 2
SM-1 vs. an Active Comparator in A Model of Transient Insomnia
United States14 participantsStarted 2020-05-27
Plain-language summary
The purpose of this study is to investigate the effectiveness, safety and tolerability of a combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult participants who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or a combination of diphenhydramine and lorazepam during 2 one-night stays at a sleep center.
Who can participate
Age range25 Years – 55 Years
SexALL
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Inclusion criteria
✓. Age 25 and 55 years
✓. Body mass index (BMI) between 19 and 32 kg/m2
✓. Report previous history of occasional difficulty falling asleep or staying asleep, but not currently having difficulty sleeping;
✓. Regular, habitual bedtime between 21:00 and 24:00, routinely spend at least 7.5 and no more than 9.0 hours in bed nightly and a bedtime that does not vary by more than 2 hours over the course of the week.
✓. Good general health
✓. Females of childbearing potential must be using an acceptable method of contraception, have a negative serum pregnancy test at screening and have a negative urine pregnancy test before randomization and prior to each Treatment Period.
✓. Female subjects who have been surgically sterilized are eligible if they have a negative serum pregnancy test at screening and negative urine pregnancy test at check-in or are post-menopausal or have had a complete hysterectomy;
✓. Male subjects must use an acceptable method of contraception during the course of the study and for the 90 days following the last dose of study medication.
Exclusion criteria
✕. Clinically significant, acute illness within 14 days prior to screening
✕. Clinically significant, unstable medical illness;
✕. Evidence or history of clinically significant allergic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease;
✕. A sitting blood pressure \> 140/90 millimeters mercury (mm/Hg) at screening;
✕. Heart rate \> 100 beats per minute (BPM) at screening;
✕. Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition;
✕. Subject has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the C-SSRS