IRB Number
|
# 24522
|
| Description |
In Subjects who have undergone
segmental colectomy, the time between the end of surgery and first bowel
movement is significantly shorter in the MOA-728 regimen than the equivalent
assessment using a placebo regimen. |
| What is expected of me? |
Participants will receive IV
Methylnaltrexone beginning in the OR and continuing until they tolerate
clear liquids, have a first bowel movement, are discharged, or a maximum of
ten days. They will be required to fill out pain and satisfaction
assessments, have bloodwork drawn, vital signs, physical, and daily review
of medications. |
| Inclusion Criteria |
- >18 yo
- Scheduled for a segmental open colectomy
- History of inflammatory bowel disease
- Body weight within 40-150 kg
|
| Exclusion Criteria |
- Scheduled laparascopic surgery
- Allergy to methylnaltrexone, naltrexone, or naloxone
- Recent history of abdominal radiation therapy
- Pregnancy
|
| Length of Study |
Patients will be required to
participate for 6 weeks. Study will be closed in approximately 13 months. |
| Study Location |
Penn State Milton S. Hershey
Medical Center |
| Investigator Information |
Walter Koltun, MD
Department of Surgery |
| To obtain more information about this study please contact: |
Walter Koltun, MD
717-531-5164
wkoltun@psu.edu, or
Lee Ann Smith, RN
717-531-0003 ext. 285155
lsmith1@psu.edu |
