A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Talphera, Inc
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- SPID-12
Study Overview
Brief Summary
The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01 treated subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
3
Oral dosage of placebo
Intervention: Placebo (Drug)
1
Oral Sufentanil
Intervention: Oral sufentanil (Drug)
2
Oral sufentanil
Intervention: Oral sufentanil (Drug)
Outcomes
Primary Outcomes
SPID-12
Time Frame: 12 hours after surgery
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.
Secondary Outcomes
- Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief(Up to 12 hours after surgery)