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CompletedNCT02800590ABP-700Updated Feb 20, 2018

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 interventional study of ABP-700 in Colonoscopy, sponsored by The Medicines Company. Completed at 3 sites in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-20.

Sponsored by The Medicines Company (part of Novartis) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 clinical development of ABP-700 in procedural sedation.

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.

02

Conditions studied

  • Colonoscopy

Keywords

  • Adult participants
  • Sedation
  • elective
03

In context

Lead sponsor

The Medicines Company is the lead sponsor of 50 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

First submitted before The Medicines Company became part of Novartis.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    ABP-700 30 μg/kg/min

    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.

    Drug: ABP-700

  • Experimental
    ABP-700 40 μg/kg/min

    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.

    Drug: ABP-700

  • Experimental
    ABP-700 45 μg/kg/min

    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.

    Drug: ABP-700

Interventions

  • DrugABP-700
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What researchers measure

Primary outcomes

  1. Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose

    Time frame: Treatment period (Day 1)

Secondary outcomes

  1. Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose with and without Supplemental Bolus ABP-700

    Time frame: Treatment period (Day 1)

  2. 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)

  3. Time to Procedure Start

    Time frame: Treatment period (Day 1)

  4. Depth and Duration of Sedation

    Time frame: Treatment period (Day 1)

  5. Number of Supplemental ABP-700 Bolus Doses Required

    Time frame: Treatment period (Day 1)

  6. Recovery from Sedation and Discharge Conditions as Assessed by the Modified Aldrete Score (APRS)

    Time frame: Treatment period (Day 1)

07

Study locations

3 sites
  • Martini Hospital
    Groningen, Netherlands
  • University Medical Center Groningen (UMCG)
    Groningen, Netherlands
  • Radboud University Nijmegen Medical Centre
    Nijmegen, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2016 to primary completion in Jun 2017, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2016
First posted
Jun 15, 2016
StartActual
May 2016
Primary completionActual
Jun 2017
CompletionActual
Jun 2017
Last update
Feb 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02800590
Responsible party
Sponsor
First posted
Jun 15, 2016
Start date
May 2016
Primary completion
Jun 2017
Completion
Jun 2017
Last update
Feb 20, 2018

Study contacts

A.R. Absalom, MD
principal investigator · University Medical Center Groningen (UMCG)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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