Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Gastroenterology
Disease Category: Constipation

Trial Information

A clinical trial for the treatment of Opioid Induced Chronic Constipation in the Chronic Pain Patient

Do you have constipation from the pain medication you are taking? You may qualify for a 52 week clinical trial for the treatment of Opioid Induced Chronic Constipation. It is a subcutaneous injection, (given just under the skin) self administered daily at home, to aide you in having daily bowel movements. If you qualify, you may be reimbursed for time and travel.

Patient Inclusion Criteria:

• Male or Female aged 18 years or older
• A history of pain of at least 2 months' duration before the screening visit due to a documented underlying nonmalignant condition
• Stable medical status for at least 1 month before screening visit
• Taking oral, transdermal, intravenous, or subcutaneous opioids daily for at least 1 month, with anticipated continuing daily opioid therapy for the duration of the study.
• A history of constipation due to opioid use during the 1 month before the screening visit. You must satisfy 2 or more of the following criteria during the month prior to the screening visit to be eligible:
  • Hard or lumpy stools for at least 25% of the bowel movements.
  • Straining during at least 25% of the bowel movements.
  • A sensation of incomplete evacuation after at least 25% of the bowel movements
  • Use of manual maneuvers (e.g. digital evacuation, support of pelvic floor) to facilitate bowel movements at least 25% of the time.
  • Fewer than 3 bowel movements per week.
• At least 1 bowel movement in the week prior to the screening visit.
• All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article.
• Willingness and ability to participate in all aspects of the study, including use of subcutaneous medication (administered by self or designee), completion of subject evaluations, attending scheduled clinic visits, and compliance with all protocol requirements as evidenced by written informed consent.
• Ambulatory, capable of all self care, and up and about more than 50% of the waking hours

Patient Exclusion Criteria:

• Received any investigational drugs or devices other than MOA-728 within 4 weeks before the administration of the first dose of test article.
• Pregnant, breastfeeding, or plans to become pregnant during the study.
• A diagnosis of bowel obstruction, fecal incontinence, rectal prolapse, or other significant GI disorders.
• A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
• A history of rectal bleeding unexplained by hemorrhoids or fissures.
• Clinical evidence of outlet obstruction or impaction.
• A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 yrs before the screening visit.
• A history of chronic constipation before the initiation of opioid therapy.
• A history of alcohol or drug abuse within 1 year before the screening visit.
• Any unstable liver, kidney, lung, heart (including uncontrolled high blood pressure) eye, nerve or psychiatric, or any other medical condition that might compromise the study or put you at risk
• A history or presence of low blood pressure upon standing
• Urine drug screening positive for a substance of abuse that is NOT explained by a prescribed medication
• Planned surgery during the study
• Known allergy to opioids
• Involvement in current litigation related to your underlying medical condition

Joan Cutillo, LPN, CCRC, Clinical Research Manager
National Pain Research Institute, LLC
1201 S. Orlando Ave.
Winter Park, FL 32789
Phone: 407-622-5766 x1420
Fax: 561-372-0219
EMail: jcutillo@natpain.com

View Google Map

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.