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Therapeutic Areas: Gastroenterology
Disease Category: Constipation

Trial Information

Do You Suffer from Constipation?

This is a Phase 3, open-label study to evaluate the efficacy and long-term safety of the study drug MOA-728 given subcutaneously in patients with opioid induced constipation. The study will last approximately 52 weeks with 15 office visits. You may be compensated for your time and travel upon completion of study.

Patient Inclusion Criteria:

• Male/female age 18 or older
• History of pain of a least 2 months before screening visit
• Stable medication for at least 1 month before screening visit
• Taking oral, trans dermal, intravenous, or subcutaneous opioids daily for at least 1 month, continued use for duration of study
• History of constipation due to opioid use for 1 month before screening
• Hard or lumpy stools for at least 25% of bowel movements, sesation or incomplete evacuation at least 25% of the time, use of manual maneuvers 25% of the time, fewer than 3 bowel movements per week
• At least 1 bowel movement in the week prior to screening visit
• Must use 2 forms of birth control throughout study

Patient Exclusion Criteria:

• Diagnosis of bowel obstruction, fecal incontinence, rectal prolapse, or other GI disorder, history of inflammatory bowel disorder, IBS, or megacolon within 6 month
• History of rectal bleeding unexplained by hemorrhoids or fissures
• History of cancer within 5 years except BSS or BCC
• History of chronic constipation before study
• Drug or alcohol abuse within 1 year of first screening
• Unstable hepatic, renal, pulmonary, cardiovascular (uncontrolled HTN), neurological, psychiatric, or any other unstable medical condition
• Positive drug screen for substance not prescribed by physician
• Received investigational drug within 4 weeks of study
• Planned surgery during study
• Allergy or sensitivity to opioids, derivitives or antagonists

Renstar Medical Research
104 SE 1st Ave., Suite B
Ocala, FL 34471
Phone: 352-629-5800

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