Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension
Condition: Pain, Postoperative; Bunion
MeSH terms: Pain, Postoperative
Intervention: COV795; Placebo
Intervention description: 2 tablets taken every 12 hours; 2 tablets taken every 12 hours
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 329.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Moderate Post-Operative Pain; Severe Post-Operative Pain; Bunionectomy

Summary:

      The primary objective of this study is to show the effectiveness of repeated doses of COV795
      versus placebo, using the summed pain intensity difference over the first 48 hours in
      subjects with acute moderate to severe pain following bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria

          1. Complete the informed consent process as documented by signed informed consent
             form(s).

          2. Be in generally good health.

          3. Be 18 to 75 years of age, inclusively at the time of screening.

          4. Be scheduled for a primary unilateral first metatarsal bunionectomy (with no
             collateral procedures).

          5. Have a body mass index ≤33 kg/m2.

          6. Female subjects are eligible only if not pregnant, not lactating, not planning to
             become pregnant for the duration of the study, surgically sterile or at least two
             years postmenopausal, or practicing an acceptable form of birth control for at least 2
             months

          7. Male subjects must be sterile or commit to the use of a reliable method of birth
             control

          8. Be classified as Physical status 1 (PS-1) to PS-2 by the American Society of
             Anesthetists (ASA) Physical Status Classification System.

          9. Be willing to complete the pain evaluations and return to the clinic as scheduled.

        Exclusion Criteria

          1. Have an uncontrolled medical condition, serious intercurrent illness, clinically
             significant general health condition, or extenuating circumstance that may
             significantly decrease study compliance or otherwise preclude their participation in
             the study.

          2. Have a clinically significant abnormal electrocardiogram (ECG) at screening

          3. Have had any type of gastric bypass surgery or have a gastric band.

          4. Have previous abdominal surgery within the past year or history of abdominal
             adhesions, known or suspected paralytic ileus.

          5. Have a history of any medical condition that would alter the absorption, distribution,
             metabolism or excretion of COV795

          6. Have a history of severe bronchial asthma, hypercarbia, or hypoxia

          7. Have a clinically significant abnormality on their clinical laboratory values

          8. Have Addison's disease, benign prostatic hyperplasia, or kidney disease

          9. Have donated blood or blood components within 3 months prior to the screening visit.

         10. Have a known allergy or hypersensitivity to any opioid analgesics, anesthetics,
             acetaminophen, Non-steroid anti-inflammatory drugs (NSAIDs).

         11. Have a history of intolerance to short term opioid use.

         12. Unwilling to discontinue certain prohibited medications within the allotted time
             before surgery and throughout the duration of the study. Have taken certain drugs
             within the indicated times before surgery.

         13. Have a history of substance or alcohol abuse and/or a positive result on drug
             screening.

         14. Have a positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV),
             or hepatitis C virus (HCV) at the screening visit.

         15. Have dysphagia and/or cannot swallow study medication whole.

         16. Have a history of migraine or frequent headaches, seizures, or are currently taking
             anticonvulsants.

         17. Have previously participated in a clinical trial using COV795 or had a bunionectomy in
             the last 3 months.

         18. Received any investigational drugs or devices within 4 weeks prior to the screening
             visit.

         19. Other criteria as specified in the trial protocol.