Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
176

Inclusion Criteria

Has a pain score within protocol-specified parameters
Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
Has a pain score within protocol-specified parameters
Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender

Exclusion Criteria

Has planned or recent drug use outside protocol-specified parameters
Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
Has oxygen-dependent conditions or oxygen saturation <95%
...
Has planned or recent drug use outside protocol-specified parameters
Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
Has oxygen-dependent conditions or oxygen saturation <95%
Has allergy to fentanyl or morphine

Summary

Conditions
Acute Pain
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criteria

Has a pain score within protocol-specified parameters
Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
Has a pain score within protocol-specified parameters
Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender

Exclusion Criteria

Has planned or recent drug use outside protocol-specified parameters
Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
Has oxygen-dependent conditions or oxygen saturation <95%
...
Has planned or recent drug use outside protocol-specified parameters
Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
Has oxygen-dependent conditions or oxygen saturation <95%
Has allergy to fentanyl or morphine

Tracking Information

NCT #
NCT02137525
Collaborators
Not Provided
Investigators
Study Director: Giovanni DeCastro INSYS Therapeutics Inc