Trial · NCT03331042
SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.
NCT03331042, Phase 3, Completed, Sequential Medicine Ltd; results first posted 2019-06-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia. Trials, record NCT03331042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03331042
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.
- NCT number
- NCT03331042
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 85 participants, actual
- Lead sponsor
- Sequential Medicine Ltd
- Conditions
- Transient Insomnia
- Interventions
- SM-1, D+Z, D+L, Placebo
- First posted
- 2017-11-06
- Last updated
- 2019-06-05
- Results first posted
- 2019-06-05
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Sleep Time (TST) | 8 hours | TST efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-defined total sleep time (TST) |
| Secondary | Latency to Persistent Sleep (LPS) | 8 hours | Efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep induction, the amount of time it takes the subject to fall asleep. |
| Secondary | Number of Awakenings (NAW) | 8 hours | NAW efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep maintenance. |
| Secondary | Wakefulness After Sleep Onset (WASO) | 8 hours | WASO efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep maintenance as the amount of time spent awake after falling asleep. |
| Secondary | Karolinska Sleepiness Scale (KSS) of Morning Alertness. | Up to Visit 5 | Morning alertness measured by Karolinska Sleepiness Scale (KSS). KSS ranges from 1-9, with higher numbers indicating sleepier and lower numbers more alert. |
| Secondary | Number Correct on Digit Symbol Substitution Test (DSST) | Up to Visit 5 | Morning alertness measured by DSST. The digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment. Scores on the DSST range from 0-93 |
| Secondary | Subjective Total Sleep Time (sTST) | Up to 22 days. | Subject reported TST from Post-Sleep Questionnaire (PSQ). |
| Secondary | Subjective Sleep Onset Latency (sSOL) | Up to 22 days. | Subject reported SOL, the amount of time the subject felt it took to fall asleep, from Post-Sleep Questionnaire (PSQ). |
| Secondary | Subjective Number of Awakenings (sNAW) | Up to 22 days. | Subject reported NAW from Post-Sleep Questionnaire (PSQ). |
| Secondary | Number of Participants According to Sleep Quality | Up to 22 days. | Subject reported sleep quality, how well the subject felt he or she slept, from Post-Sleep Questionnaire (PSQ). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Sleep Time (TST) | 8 hours | Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug. | minutes | MEAN |
| SECONDARY | Latency to Persistent Sleep (LPS) | 8 hours | Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug. | minutes | MEAN |
| SECONDARY | Number of Awakenings (NAW) | 8 hours | Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug. | awakenings | MEAN |
| SECONDARY | Wakefulness After Sleep Onset (WASO) | 8 hours | Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug. | minutes | MEAN |
| SECONDARY | Karolinska Sleepiness Scale (KSS) of Morning Alertness. | Up to Visit 5 | The Safety Population included all subjects that received any study drug, and were grouped by actual treatment. | units on a scale | MEAN |
| SECONDARY | Number Correct on Digit Symbol Substitution Test (DSST) | Up to Visit 5 | Safety Population included all subjects that received any study drug, and were grouped by actual treatment. | number correct | MEAN |
| SECONDARY | Subjective Total Sleep Time (sTST) | Up to 22 days. | All subjects who were randomized to a treatment sequence, and had taken any study drug. | minutes | MEAN |
| SECONDARY | Subjective Sleep Onset Latency (sSOL) | Up to 22 days. | All subjects who were randomized to a treatment sequence, and had taken any study drug. | minutes | MEAN |
| SECONDARY | Subjective Number of Awakenings (sNAW) | Up to 22 days. | All subjects who were randomized to a treatment sequence, and had taken any study drug. | awakenings | MEAN |
| SECONDARY | Number of Participants According to Sleep Quality | Up to 22 days. | All subjects who were randomized to a treatment sequence, and had taken any study drug. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Sleep Time (TST) | SM-1 | 401.82 | Standard Deviation 68.074 | minutes | |
| Total Sleep Time (TST) | Diphenhydramine Plus Zolpidem | 404.83 | Standard Deviation 47.252 | minutes | |
| Total Sleep Time (TST) | Diphenhydramine Plus Lorazepam | 397.28 | Standard Deviation 56.982 | minutes | |
| Total Sleep Time (TST) | Placebo | 307.38 | Standard Deviation 107.365 | minutes | |
| Latency to Persistent Sleep (LPS) | SM-1 | 18.59 | Standard Deviation 18.548 | minutes | |
| Latency to Persistent Sleep (LPS) | Diphenhydramine and Zolpidem | 23.10 | Standard Deviation 29.145 | minutes | |
| Latency to Persistent Sleep (LPS) | Diphenhydramine and Lorazepam | 23.55 | Standard Deviation 29.125 | minutes | |
| Latency to Persistent Sleep (LPS) | Placebo | 39.25 | Standard Deviation 73.961 | minutes | |
| Number of Awakenings (NAW) | SM-1 | 11.0 | Standard Deviation 6.06 | awakenings | |
| Number of Awakenings (NAW) | Diphenhydramine and Zolpidem | 10.7 | Standard Deviation 6.22 | awakenings |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence 1 | 22 | |
| Overall Study | STARTED | Sequence 2 | 21 | |
| Overall Study | STARTED | Sequence 3 | 21 | |
| Overall Study | STARTED | Sequence 4 | 21 | |
| Overall Study | COMPLETED | Sequence 1 | 21 | |
| Overall Study | COMPLETED | Sequence 2 | 21 | |
| Overall Study | COMPLETED | Sequence 3 | 20 | |
| Overall Study | COMPLETED | Sequence 4 | 20 | |
| Overall Study | NOT COMPLETED | Sequence 1 | 1 | |
| Overall Study | NOT COMPLETED | Sequence 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nightmare | Nervous system disorders | SM-1 | 1 | 84 | 1 |
| other | nightmare | Nervous system disorders | Diphenhydramine Plus Zolpidem | 0 | 83 | 0 |
| other | nightmare | Nervous system disorders | Diphenhydramine Plus Lorazepam | 0 | 83 | 0 |
| other | nightmare | Nervous system disorders | Placebo | 0 | 83 | 0 |
| other | somnolence | Nervous system disorders | SM-1 | 1 | 84 | 1 |
| other | somnolence | Nervous system disorders | Diphenhydramine Plus Zolpidem | 1 | 83 | 1 |
| other | somnolence | Nervous system disorders | Diphenhydramine Plus Lorazepam | 0 | 83 | 0 |
| other | somnolence | Nervous system disorders | Placebo | 1 | 83 | 1 |
| other | abdominal pain | Gastrointestinal disorders | SM-1 | 0 | 84 | 0 |
| other | abdominal pain | Gastrointestinal disorders | Diphenhydramine Plus Zolpidem | 1 | 83 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SM-1 | 0 | 84 |
| Total, all-cause mortality | Diphenhydramine Plus Zolpidem | 0 | 83 |
| Total, all-cause mortality | Diphenhydramine Plus Lorazepam | 0 | 83 |
| Total, all-cause mortality | Placebo | 0 | 83 |
| Total, other adverse events | SM-1 | 3 | 84 |
| Total, other adverse events | Diphenhydramine Plus Zolpidem | 2 | 83 |
| Total, other adverse events | Diphenhydramine Plus Lorazepam | 1 | 83 |
| Total, other adverse events | Placebo | 1 | 83 |
| Total, serious adverse events | SM-1 | 0 | 84 |
| Total, serious adverse events | Diphenhydramine Plus Zolpidem | 0 | 83 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03331042
GET https://conductscience.org/api/trials/v1/NCT03331042/results?page=2