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

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ClinicalTrials.gov Identifier: NCT02800590
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Tracking Information
First Submitted Date  ICMJE June 10, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date February 20, 2018
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose [ Time Frame: Treatment period (Day 1) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Number of Successfully Completed Procedures [ Time Frame: Treatment period (Day 1) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Number of Successfully Completed Procedures that Allow Supplemental ABP-700 Dosing [ 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 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedation in Adult Participants Undergoing Colonoscopy
Official Title  ICMJE 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
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Colonoscopy
Intervention  ICMJE Drug: ABP-700
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: ABP-700
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800590
Other Study ID Numbers  ICMJE MDCO-ABP-15-01
2015-004019-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Medicines Company
Study Sponsor  ICMJE The Medicines Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: A.R. Absalom, MD University Medical Center Groningen (UMCG)
PRS Account The Medicines Company
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP