POI 301
Protocol Number: 3200L2-301-WW
Therapeutic Area: Surgery
Summary:
This study will examine the effect of IV MOA-728 versus placebo in shortening the time to return of bowel function in subjects receiving opioid analgesia administered via PCA, who have undergone repair of large ≥10 cm, measured from edge to edge in its greatest dimension) ventral hernias with or without a mesh prosthesis.
Inclusion Criteria:
- Subjects must meet the American Society of Anesthesiologists (ASA) physical status I, II or III
- Subjects must be scheduled for repair of a large (estimated to be at least > 10 cm) ventral hernia with or without mesh prosthesis via laparotomy or laparoscopy with general anesthesia.
- Body weight within the range of 40 to 150 kg (88 to 330 lb).
Exclusion Criteria:
- Subjects taking tricyclic antidepressants
- Known history of chronic active hepatitis B, hepatitis C virus or human immunodeficiency virus (HIV) infection.
*Additional Eligibility Criteria Exist*
Center Name: Mercy Research Institute at Mercy Hospital
Contact Information: Mercy Research Institute Clinical Trial Coordinators
Address: 3659 South Miami Avenue, Suite 3001, Miami, Florida 33133
Phone: (305) 854-4400, ext. 2312
Fax: (305) 285-2791
E-mail: rhumphreys@mercymiami.org