Trial · Interventional
CompletedPhase 2/3Registry dataA Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery
Overview
- Status
- Completed
- Phase
- Phase 2/3
- Enrollment
- 451 participants (actual)
- Sponsor
- Cara Therapeutics, Inc. · Industry
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Sept 2015
- Primary completion
- Apr 2018
- Completion
- Jun 2018
- First posted
- 7 Sept 2015 (estimated)
- Last update posted
- 31 May 2019
- Conditions
- Post Abdominal Surgery Pain
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2/3
A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery
NCT02542384Sept 2015 to Jun 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The study schedule is comprised of a 14-day Screening Period, a treatment period and an observation period. All eligible subjects will be randomized into one of 3 treatment groups (1 of 2 dose levels or matched placebo). Study drug CR845 will be administered intravenously prior to surgery, and at specific time intervals post surgery. Additional rescue pain and anti-nausea medication will be made available. Post surgical changes in pain intensity, nausea and vomiting will be assessed.
Interventions
- CR845 IV 1 mcg/kgDrug
- CR845 IV 0.5 mcg/kgDrug
- Placebo IVDrug
Arms3
Active comparator
CR845 IV 1 mcg/kg
CR845 IV solution will be supplied in 2 mL glass vials.Study drug will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight.
Active comparator
CR845 IV 0.5 mcg/kg
CR845 solution will be supplied in 2 mL glass vials. Study drug will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight.
Placebo comparator
Placebo IV
Placebo will be supplied in matched vials containing the same volume of buffer but with no active drug. It will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight.
Primary outcomes1
Outcomes the sponsor listed as primary.
A comparison of the change in Pain Intensity over time using the Numeric Rating Scale
Time frame · 24 hours
Registry description
Using the Numeric Rating Scale (NRS) to quantify the difference between CR845-treated patients and placebo-treated patients.
Secondary outcomes(3)
A study of the comparison of Post Surgical Nausea and Vomiting (PONV) scores
Time frame · 6 hours
Registry description
Incidence of vomiting will be analyzed against placebo
A comparison of the number of rescue medication doses administered
Time frame · 24 hours
Registry description
Count the number of rescue medication doses administered following surgery for the CR845 IV patients vs Placebo-treated patients
Patient Global Assessment of study drug
Time frame · 24 hours (or early termination)
Registry description
Patients will complete a PGA (Patient Global Assessment) of the study drug.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 21 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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