Acute Pain Clinical Trial
— APOLLO-1Official title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
NCT number | NCT02815709 |
Other study ID # | CP130-3001 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | January 2017 |
Verified date | September 2020 |
Source | Trevena Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.
Status | Completed |
Enrollment | 418 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. - Experiences a pain intensity rating of moderate to severe acute pain. - Able to provide written informed consent before any study procedure. Exclusion Criteria: - ASA Physical Status Classification System classification of P3 or worse. - Has surgical or post-surgical complications. - Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs. - Has previously participated in another TRV130 clinical study. |
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Anaheim | California |
United States | Research Site | Austin | Texas |
United States | Research Site | Pasadena | California |
United States | Research Site | Pasadena | Maryland |
United States | Research Site | Phoenix | Arizona |
United States | Resarch Site | Salt Lake City | Utah |
United States | Research Site | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Trevena Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. | 48 hours | ||
Secondary | Number of Respiratory Safety Events Compared to Morphine. | 48 hours | ||
Secondary | Duration of Respiratory Safety Events Compared to Morphine. | 48 hours | ||
Secondary | Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine. | Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure. | 48 hours | |
Secondary | Number of Patients With Treatment-related Adverse Events. | 48 hours |
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