SedationPhase 2NCT01145222

Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy

A Phase 2 study testing A. CNS 7056, B. CNS 7056 and C. CNS 7056 in people with Sedation, run by Paion UK Ltd. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Sedation
What is being tested?: A. CNS 7056, B. CNS 7056 and C. CNS 7056
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 9 sitesUnited States
Study dates: May 2010to Oct 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients, aged 18 to 70 years inclusive, scheduled to undergo a standard colonoscopy.
American Society of Anesthesiologists Physical Status (ASA PS) Score I, II, or III.
Weight range 55 to 130 kg inclusive.
Body mass index (BMI) range 18 to 33 kg/m2 inclusive
Patients of child-bearing potential and their partners must have been willing to use adequate contraception such as an intrauterine device, diaphragm or condom during the study and until 1 month after the last study drug administration. Childbearing potential was defined as "all patients unless they were a female post menopausal for at least 2 years, or were surgically sterile."
Patient voluntarily signed and dated an ICF that was approved by an IRB prior to the conduct of any study procedure.
Patient was willing and able to comply with study requirements and return for a Follow up Visit (Day 4 ± 3 day) after the colonoscopy.

Who cannot join

Expected duration of colonoscopy > 30 minutes.
Patients with a suspected or diagnosed pathology of the lower GI tract that would have added to the risk of colonoscopy, such as strictures, active inflammatory bowel disease.
ASA III patients with history of sleep apnea.
ASA III patients with obesity (BMI ≥ 30 kg/m2).
Patients with evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction, or other clinically significant (CS) findings at screening that, in the investigator's or medical monitor's opinion, should have excluded them from the study.
Patients with clinically significant abnormalities in 12 lead ECG recorded at screening.

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Female patients with a positive serum human chorionic gonadotropin (HCG) pregnancy test at screening or baseline.
Lactating female patients.
Patients with positive drugs of abuse screen at baseline.
Patients with positive serum ethanol at baseline.
Patient with a history of drug or ethanol abuse.
Patients in receipt of any investigational drug within 30 days or less than 7 half lives (whichever was longer) before the start of the study, or scheduled to receive one during the study period.
Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
Patients with an inability to communicate well with the investigator.
Patients in whom management of airway was judged to be difficult due to, e.g., thyro-mental distance ≤ 4 cm ("short neck"), or Mallampati score of 4.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

ACRI Phase I LLC
Anaheim, California, 92801
Advanced Clinical Research Associates
Anaheim, California, 92801
Charlottesville Medical Research
Charlottesville, Virginia, 22911
HOPE Research Institute
Phoenix, Arizona, 85050
Wake Research Associates
Raleigh, North Carolina, 27612
Helen Keller Hospital
Sheffield, Alabama, 35660
Miami Research Associates
South Miami, Florida, 33143
Stony Brook University Medical Center
Stony Brook, New York, 11794
Options Health Research
Tulsa, Oklahoma, 74104

Other trials in United States

About this study

Official title: A Phase IIb Study Evaluating the Safety and Efficacy of Multiple Doses of CNS 7056 Compared to Midazolam in Patients Undergoing Colonoscopy

The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.

Read the detailed description

This is a double-blind, randomized, parallel group, dose-response study to assess the safety and efficacy of three dose levels of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.

Safety assessment will include physical examinations, vital signs, ECGs, pulse oximetry measurements, capnography, clinical chemistry and hematology laboratory tests, routine drug and ethanol screening, urinalysis, pregnancy test, pain on injection using a verbal scale, and monitoring of adverse events.

Conditions: Sedation
Being tested: A. CNS 7056, B. CNS 7056, C. CNS 7056, D. Midazolam
Keywords: CNS 7056, Procedural Sedation, Colonoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

A. CNS 7056Drug
Also called CAS No. 1001415-66-2, Remimazolam
Initial low dose plus supplemental doses as necessary.
B. CNS 7056Drug
Also called CAS No. 1001415-66-2, Remimazolam
Initial intermediate dose plus supplemental doses as necessary.
C. CNS 7056Drug
Also called CAS No. 1001415-66-2, Remimazolam
Initial high dose plus supplemental doses as necessary.
D. MidazolamDrug
Also called CAS No. 59467-96-8
Initial standardized dose plus supplemental doses as necessary.

Study groups in NCT01145222
Study group	Role	What they receive
A. Remimazolam (CNS 7056)	Experimental	Initial 8 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. Receives: Drug: A. CNS 7056
B. Remimazolam (CNS 7056)	Experimental	Initial 7 mg iv for sedation induction, and 2 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. Receives: Drug: B. CNS 7056
C. Remimazolam (CNS 7056)	Experimental	Initial 5 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. Receives: Drug: C. CNS 7056
D. Midazolam	Active comparator	Initial 2.5 mg iv for sedation induction, and 1 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses Receives: Drug: D. Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

Success Rates of the Procedure
Success of the procedure is a composite endpoint consisting of: Modified Observer's Assessment for Alertness/Sedation (MOAA/S) scores ≤4 on three consecutive measurements after administration of study drug AND completion of the endoscopy procedure AND no requirement for rescue sedative medication AND no requirement for manual or mechanical ventilation
Measured: From start of study drug injection to patient discharge

Secondary outcomes (2)

Time to Fully Alert
Time to first of 3 consecutive MOAA/S scores of 5 after the last injection of double-blind study medication
Measured: From last injection of double-blind study medication until fully alert criteria are reached
Time to Ready for Discharge
Time of the first of 3 consecutive Aldrete scores ≥ 9
Measured: After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores ≥ 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Oct 2010

First posted16 Jun 2010 (estimated)
Study startMay 2010
Primary completionSep 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SedationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01145222
Sponsor's protocol ID: CNS 7056-004
Status last verified: Dec 2018
First submitted: 27 May 2010
Last updated: 8 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Pambianco DJ, Borkett KM, Riff DS, Winkle PJ, Schwartz HI, Melson TI, Wilhelm-Ogunbiyi K. A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):984-92. doi: 10.1016/j.gie.2015.08.062. Epub 2015 Sep 9.
PubMed 26363333

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb Study Evaluating the Safety and Efficacy of Multiple Doses of CNS 7056 Compared to Midazolam in Patients Undergoing Colonoscopy
ClinicalTrials.gov ID: NCT01145222
Acronym / sponsor ID: CNS 7056-004
Conditions: Sedation
Keywords: CNS 7056, Procedural Sedation, Colonoscopy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Paion UK Ltd.Industry (pharma, biotech, devices)
Collaborators: Premier Research
Study start: May 2010
Primary completion: Sep 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 16 Jun 2010 (estimated)
Results: Posted 8 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
A. Remimazolam (CNS 7056)	Experimental	Drug: A. CNS 7056Initial 8 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses.
B. Remimazolam (CNS 7056)	Experimental	Drug: B. CNS 7056Initial 7 mg iv for sedation induction, and 2 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses.
C. Remimazolam (CNS 7056)	Experimental	Drug: C. CNS 7056Initial 5 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses.
D. Midazolam	Active comparator	Drug: D. MidazolamInitial 2.5 mg iv for sedation induction, and 1 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male and female patients, aged 18 to 70 years inclusive, scheduled to undergo a standard colonoscopy.
American Society of Anesthesiologists Physical Status (ASA PS) Score I, II, or III.
Weight range 55 to 130 kg inclusive.
Body mass index (BMI) range 18 to 33 kg/m2 inclusive
Patients of child-bearing potential and their partners must have been willing to use adequate contraception such as an intrauterine device, diaphragm or condom during the study and until 1 month after the last study drug administration. Childbearing potential was defined as "all patients unless they were a female post menopausal for at least 2 years, or were surgically sterile."

Key exclusion criteria (15 listed)

Expected duration of colonoscopy > 30 minutes.
Patients with a suspected or diagnosed pathology of the lower GI tract that would have added to the risk of colonoscopy, such as strictures, active inflammatory bowel disease.
ASA III patients with history of sleep apnea.
ASA III patients with obesity (BMI ≥ 30 kg/m2).
Patients with evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction, or other clinically significant (CS) findings at screening that, in the investigator's or medical monitor's opinion, should have excluded them from the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
A. CNS 7056Also: CAS No. 1001415-66-2, RemimazolamInitial low dose plus supplemental doses as necessary.	Drug	A. Remimazolam (CNS 7056)
B. CNS 7056Also: CAS No. 1001415-66-2, RemimazolamInitial intermediate dose plus supplemental doses as necessary.	Drug	B. Remimazolam (CNS 7056)
C. CNS 7056Also: CAS No. 1001415-66-2, RemimazolamInitial high dose plus supplemental doses as necessary.	Drug	C. Remimazolam (CNS 7056)
D. MidazolamAlso: CAS No. 59467-96-8Initial standardized dose plus supplemental doses as necessary.	Drug	D. Midazolam

Primary outcome

Success Rates of the Procedure
Time frame: From start of study drug injection to patient discharge
Success of the procedure is a composite endpoint consisting of: Modified Observer's Assessment for Alertness/Sedation (MOAA/S) scores ≤4 on three consecutive measurements after administration of study drug AND completion of the endoscopy procedure AND no requirement for rescue sedative medication AND no requirement for manual or mechanical ventilation

2 secondary outcomes

Time to Fully Alert
Time frame: From last injection of double-blind study medication until fully alert criteria are reached
Time to Ready for Discharge
Time frame: After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores ≥ 9

Results and safety

Results posted to the registry on 8 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remimazolam 8.0/3.0 mg	40	40
Remimazolam 7.0/2.0 mg	40	40
Remimazolam 5.0/3.0 mg	41	40
Midazolam 2.5/1.0	41	40

Primary outcome: Success Rates of the Procedure

Time frame: From start of study drug injection to patient discharge. Count of participants. Unit: Participants

Measure	Remimazolam 8.0/3.0 mg n = 40	Remimazolam 7.0/2.0 mg n = 40	Remimazolam 5.0/3.0 mg n = 40	Midazolam 2.5/1.0 n = 40
Value	37	38	39	30

Remimazolam 8.0/3.0 mg vs Remimazolam 7.0/2.0 mg vs Remimazolam 5.0/3.0 mg vs Midazolam 2.5/1.0: p = 0.007, Fisher Exact

Population analysed: Analysis Population is the ITT Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until Day 4 ± 3 days, and were followed until resolution of any ongoing TEAE up to 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remimazolam 8.0/3.0 mg	0 of 40 (0%)	10 of 40 (25%)	0 of 40
Remimazolam 7.0/2.0 mg	0 of 40 (0%)	8 of 40 (20%)	0 of 40
Remimazolam 5.0/3.0 mg	0 of 40 (0%)	9 of 40 (22.5%)	0 of 40
Midazolam 2.5/1.0	0 of 41 (0%)	6 of 41 (14.6%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26363333Pambianco DJ, Borkett KM, Riff DS, Winkle PJ, Schwartz HI, Melson TI, Wilhelm-Ogunbiyi K. A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):984-92. doi: 10.1016/j.gie.2015.08.062. Epub 2015 Sep 9.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A. CNS 7056, B. CNS 7056 and C. CNS 7056 in people with Sedation, run by Paion UK Ltd. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success Rates of the Procedure (time frame: From start of study drug injection to patient discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01145222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.