ColonoscopyPhase 2ABP-700NCT02800590

Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedation in Adult Participants Undergoing Colonoscopy

A Phase 2 study testing ABP-700 in people with Colonoscopy, run by The Medicines Company at 3 sites in Netherlands.

Completed

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

Trial summary

This is a phase II, two-part, multiple-dose, dose-finding, single-blind study in adult participants undergoing elective colonoscopy for screening or diagnostic purposes. This study is designed to test various ABP-700 infusion regimens for rational selection of one or more dosage regimen(s) to be used for future… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Colonoscopy
What is being tested?: ABP-700
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 3 sitesNetherlands
Study dates: May 2016to Jun 2017
Phase: Phase 2
Are there results?: None posted in the registry

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant must be male or female 18 to 75 years of age, inclusive
Participant must give written informed consent before initiation of any study-related procedures
Participant is scheduled to undergo elective colonoscopy
Body Mass Index (BMI) 18.0 to 29.0 kilogram per meter squared (kg/m^2)
American Society of Anesthesiology (ASA) class I to II
Modified Mallampati score I to II
If female and of child-bearing potential, participant must have a negative pregnancy test during screening and cannot be breast-feeding
If participant is a sexually active male or a sexually active female of child-bearing potential, he or she must agree to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits

Who cannot join

Any ASA physical status III or worse, or history of one or more of the following: history or presence of significant cardiovascular disease, including atrial fibrillation or cardiovascular disease risk factors, hyperlipidemia, coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome, > 450 milliseconds [msec]); history of any neurological or seizure disorder or psychiatric disease; history or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic or dermatologic disease; history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
History of any recent illness (such as, upper respiratory infection) that does not satisfy ASA III or greater requirements but in the opinion of the investigator, may pose an additional risk to the participant by their participation in the study.
Participants with a history of essential hypertension that are not well controlled on medication will be accepted. Participants should have been diagnosed with hypertension for at least 6 months and/or are not on stable therapy for at least 4 weeks prior to the study.
Surgery within the past 90 days prior to dosing judged by the investigator to be clinically relevant.
History of febrile illness within 5 days prior to dosing.
Participants in whom airway management is judged to be potentially difficult; thyromental distance ≤ 4 centimeters (cm) or Mallampati scores of 3 or 4 or per the discretion of the anesthesiologist based on history and physical exam.

Show all 11Show fewer

History or presence of alcoholism, drug abuse, or illicit drug use within the past 2 years.
Hypersensitivity or idiosyncratic reaction to components of ABP-700 (sulfobutylether-beta-cyclodextrin, citrate buffer, sodium hydroxide), remifentanil or midazolam.
Participant is the investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
Participation in another interventional clinical trial within 90 days prior to dosing. The 90-day window will be derived from the date of the last study procedure (such as last blood collection or dosing) in the previous study to Day 1 of the current study.
Participants who, for any reason, are deemed by the investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator.

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

Martini Hospital
Groningen
University Medical Center Groningen (UMCG)
Groningen
Radboud University Nijmegen Medical Centre
Nijmegen

Other trials in Netherlands

About this study

Official title: A Phase II, Two-part, Multiple-dose, Dose-finding, Single-blind Study to Investigate the Safety and Efficacy of ABP-700 for Procedural Sedation in Adult Patients Undergoing Colonoscopy

Read the detailed description

In Part 1, three ABP-700 two-stage infusion regimens will be evaluated. A sample size of 75 evaluable participants will be randomly assigned to dose regimens in a 1:1:1 ratio. Following the completion of Part 1, a Data Review Committee (DRC) will review the dose-response, efficacy, and safety data and provide recommendations on whether to continue the study to Part 2 and the number of ABP-700 infusion regimens to be included in Part 2. The Sponsor (MDCO) will make the final decision to proceed with Part 2 (whether to conduct Part 2 and number of dose regimens if the study continues to Part 2) based on the recommendation from the DRC.

Conditions: Colonoscopy
Being tested: ABP-700
Keywords: Adult participants, Sedation, elective

What participants receive

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

ABP-700Drug

Study groups in NCT02800590
Study group	Role	What they receive
ABP-700 30 μg/kg/min	Experimental	Starting intravenous (IV) infusion rate of 50 micrograms per kilogram per minute (μg/kg/min) for 5 minutes, followed by 30 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions. Receives: Drug: ABP-700
ABP-700 40 μg/kg/min	Experimental	Starting IV infusion rate of 70 μg/kg/min for 3 minutes, followed by 40 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions. Receives: Drug: ABP-700
ABP-700 45 μg/kg/min	Experimental	Starting IV infusion rate of 80 μg/kg/min for 3 minutes, followed by 45 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions. Receives: Drug: ABP-700

What is being measured

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

Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose
Measured: Treatment period (Day 1)

Secondary outcomes (6)

Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700
Measured: Treatment period (Day 1)
Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700 that Require or Do Not Require Rescue Sedative Medication
Measured: Treatment period (Day 1)
Time to Procedure Start
Measured: Treatment period (Day 1)
Depth and Duration of Sedation
Measured: Treatment period (Day 1)
Number of Supplemental ABP-700 Bolus Doses Required
Measured: Treatment period (Day 1)
Recovery from Sedation and Discharge Conditions as Assessed by the Modified Aldrete Score (APRS)
Measured: Treatment period (Day 1)

Timeline

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

May 2016Jun 2017

First posted15 Jun 2016 (estimated)
Study startMay 2016
Primary completionJun 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ColonoscopyStudies 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: Single blind
Who is masked: Participant
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02800590
Sponsor's protocol ID: MDCO-ABP-15-01
Other IDs: 2015-004019-19, 2015
Acronym: ABP-700
Status last verified: Feb 2018
First submitted: 10 Jun 2016
Last updated: 20 Feb 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Two-part, Multiple-dose, Dose-finding, Single-blind Study to Investigate the Safety and Efficacy of ABP-700 for Procedural Sedation in Adult Patients Undergoing Colonoscopy
ClinicalTrials.gov ID: NCT02800590
Acronym / sponsor ID: ABP-700 / MDCO-ABP-15-01
Conditions: Colonoscopy
Keywords: Adult participants, Sedation, elective
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: The Medicines CompanyIndustry (pharma, biotech, devices)
Study start: May 2016 (actual)
Primary completion: Jun 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 15 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
ABP-700 30 μg/kg/min	Experimental	Drug: ABP-700Starting intravenous (IV) infusion rate of 50 micrograms per kilogram per minute (μg/kg/min) for 5 minutes, followed by 30 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions.
ABP-700 40 μg/kg/min	Experimental	Drug: ABP-700Starting IV infusion rate of 70 μg/kg/min for 3 minutes, followed by 40 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions.
ABP-700 45 μg/kg/min	Experimental	Drug: ABP-700Starting IV infusion rate of 80 μg/kg/min for 3 minutes, followed by 45 μg/kg/min until the procedure is complete. Up to 2 supplemental bolus injections of 50 μg/kg ABP-700 separated by a minimum of 5 minutes may be administered in order to achieve and/or maintain adequate procedure conditions.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participant must be male or female 18 to 75 years of age, inclusive
Participant must give written informed consent before initiation of any study-related procedures
Participant is scheduled to undergo elective colonoscopy
Body Mass Index (BMI) 18.0 to 29.0 kilogram per meter squared (kg/m^2)
American Society of Anesthesiology (ASA) class I to II

Key exclusion criteria (11 listed)

Any ASA physical status III or worse, or history of one or more of the following: history or presence of significant cardiovascular disease, including atrial fibrillation or cardiovascular disease risk factors, hyperlipidemia, coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome, > 450 milliseconds [msec]); history of any neurological or seizure disorder or psychiatric disease; history or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic or dermatologic disease; history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
History of any recent illness (such as, upper respiratory infection) that does not satisfy ASA III or greater requirements but in the opinion of the investigator, may pose an additional risk to the participant by their participation in the study.
Participants with a history of essential hypertension that are not well controlled on medication will be accepted. Participants should have been diagnosed with hypertension for at least 6 months and/or are not on stable therapy for at least 4 weeks prior to the study.
Surgery within the past 90 days prior to dosing judged by the investigator to be clinically relevant.
History of febrile illness within 5 days prior to dosing.

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
ABP-700	Drug	ABP-700 30 μg/kg/min, ABP-700 40 μg/kg/min, ABP-700 45 μg/kg/min

Primary outcome

Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose
Time frame: Treatment period (Day 1)

6 secondary outcomes

Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700
Time frame: Treatment period (Day 1)
Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700 that Require or Do Not Require Rescue Sedative Medication
Time frame: Treatment period (Day 1)
Time to Procedure Start
Time frame: Treatment period (Day 1)
Depth and Duration of Sedation
Time frame: Treatment period (Day 1)
Number of Supplemental ABP-700 Bolus Doses Required
Time frame: Treatment period (Day 1)
Recovery from Sedation and Discharge Conditions as Assessed by the Modified Aldrete Score (APRS)
Time frame: Treatment period (Day 1)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
Individual participant dataSharing planned: No

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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.

A.R. Absalom, MD principal investigator

University Medical Center Groningen (UMCG)

3 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 ABP-700 in people with Colonoscopy, run by The Medicines Company at 3 sites in Netherlands.

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 8 inclusion and 11 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose (time frame: Treatment period (Day 1)). 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 NCT02800590.

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 20 Feb 2018.