Trial · NCT02290873
A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
NCT02290873, Phase 3, Completed, Paion UK Ltd.; results first posted 2018-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients. Trials, record NCT02290873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02290873
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
- NCT number
- NCT02290873
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 461 participants, actual
- Lead sponsor
- Paion UK Ltd.
- Conditions
- Colonoscopy
- Interventions
- Remimazolam, Midazolam, Placebo
- First posted
- 2014-11-14
- Last updated
- 2020-10-20
- Results first posted
- 2018-11-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success Rates of the Procedure | From administration of the first dose of the study drug to the end of colonoscopy | Success of the Procedure is measured by completion of colonoscopy, no requirement for an alternative sedative and no requirement for more than 5 top-ups of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the midazolam arm. |
| Secondary | Time to Start of Procedure | From first dose of study drug until insertion of the colonoscope | The time to the start of the procedure after administration of the first dose of randomized study drug |
| Secondary | Time to Fully Alert | From the end of colonoscopy (colonoscope out) until the patient has recovered to fully alert and from the last injection of the study drug or rescue sedative medication until the patient has recovered to fully alert | The time to fully alert (time to first of three consecutive Modified Observer's Assessment of Alertness/Sedation \[MOAA/S\] scores of 5) after the end of colonoscopy procedure \[colonoscope out\], and after the last dose of study drug or rescue sedative medication |
| Secondary | Time to Ready for Discharge | From the end of the colonoscopy until discharge (expected to be the same day). After the last dose of study drug or rescue sedative, until discharge (expected to be the same day). | The time after the end of colonoscopy procedure (colonoscope out) and after the last injection of study drug or rescue sedative medication, until discharge (defined as ability to walk unassisted). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Success Rates of the Procedure | From administration of the first dose of the study drug to the end of colonoscopy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Start of Procedure | From first dose of study drug until insertion of the colonoscope | Patients who do not reach the endpoint are excluded from the analysis. | minutes | MEDIAN |
| SECONDARY | Time to Fully Alert | From the end of colonoscopy (colonoscope out) until the patient has recovered to fully alert and from the last injection of the study drug or rescue sedative medication until the patient has recovered to fully alert | Patients who do not reach the endpoint are censored at last MOAA/S | minutes | MEDIAN |
| SECONDARY | Time to Ready for Discharge | From the end of the colonoscopy until discharge (expected to be the same day). After the last dose of study drug or rescue sedative, until discharge (expected to be the same day). | minutes | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Success Rates of the Procedure | Remimazolam | 272 | Participants | ||
| Success Rates of the Procedure | Placebo | 1 | Participants | ||
| Success Rates of the Procedure | Midazolam | 26 | Participants | ||
| Time to Start of Procedure | Remimazolam | 4 | Inter-Quartile Range 3.0 to 6.0 | minutes | |
| Time to Start of Procedure | Placebo | 19.5 | Inter-Quartile Range 17.0 to 23.0 | minutes | |
| Time to Start of Procedure | Midazolam | 19 | Inter-Quartile Range 12.0 to 21.0 | minutes | |
| Time to Fully Alert | Remimazolam | After the end of colonoscopy | 6 | 95% Confidence Interval 5 to 7 | minutes |
| Time to Fully Alert | Placebo | After the end of colonoscopy | 15 | 95% Confidence Interval 13 to 21 | minutes |
| Time to Fully Alert | Midazolam | After the end of colonoscopy | 13 | 95% Confidence Interval 11 to 16 | minutes |
| Time to Fully Alert | Remimazolam | After last dose of study drug or rescue sedative | 14 | 95% Confidence Interval 13 to 14 | minutes |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Remimazolam | 298 | |
| Overall Study | STARTED | Placebo | 60 | |
| Overall Study | STARTED | Midazolam | 103 | |
| Overall Study | Modified Intention to Treat (mITT) | Remimazolam | 296 | |
| Overall Study | Modified Intention to Treat (mITT) | Placebo | 60 | |
| Overall Study | Modified Intention to Treat (mITT) | Midazolam | 102 | |
| Overall Study | Safety Population | Remimazolam | 296 | |
| Overall Study | Safety Population | Placebo | 60 | |
| Overall Study | Safety Population | Midazolam | 102 | |
| Overall Study | COMPLETED | Remimazolam | 296 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events24
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 | Hypotension | Vascular disorders | Remimazolam | 115 | 296 | |
| other | Hypotension | Vascular disorders | Placebo | 25 | 60 | |
| other | Hypotension | Vascular disorders | Midazolam | 63 | 102 | |
| other | Hypertension | Vascular disorders | Remimazolam | 59 | 296 | |
| other | Hypertension | Vascular disorders | Placebo | 17 | 60 | |
| other | Hypertension | Vascular disorders | Midazolam | 18 | 102 | |
| other | Bradycardia | Cardiac disorders | Remimazolam | 33 | 296 | |
| other | Bradycardia | Cardiac disorders | Placebo | 7 | 60 | |
| other | Bradycardia | Cardiac disorders | Midazolam | 16 | 102 | |
| other | Diastolic Hypertension | Vascular disorders | Remimazolam | 29 | 296 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Remimazolam | 0 | 296 |
| Total, all-cause mortality | Placebo | 0 | 60 |
| Total, all-cause mortality | Midazolam | 0 | 102 |
| Total, other adverse events | Remimazolam | 218 | 296 |
| Total, other adverse events | Placebo | 47 | 60 |
| Total, other adverse events | Midazolam | 93 | 102 |
| Total, serious adverse events | Remimazolam | 0 | 296 |
| Total, serious adverse events | Placebo | 0 | 60 |
| Total, serious adverse events | Midazolam | 0 | 102 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT02290873
GET https://conductscience.org/api/trials/v1/NCT02290873/events?page=2