A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

Condition	Treatment or Intervention	Phase
Constipation Bowel dysfunction	Drug: Investigational opioid -induced bowel dysfunction drug	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Subject is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.
• Subject is taking opioid therapy for persistent cancer pain. Meperidine and propoxyphene are excluded.
• Subject meets the definition of opioid-induced bowel dysfunction as follows: *Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms [sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)].
• Subject understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.
• Subject is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.

Exclusion criteria:

• Subject is pregnant or lactating, or planning to become pregnant.
• Subject is not ambulatory.
• Subject has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.
• Subject is unable to eat, drink, take/hold down oral medications.
• Subject is taking opioids for the management of drug addiction.
• Subject is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study.
• Subject has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit.
• Subject with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
• Subject is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.
• Subject is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.
• Subject is HIV-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.

Arkansas
      Hot Springs,  Arkansas,  71913,  United States; Recruiting
California
      Los Angeles,  California,  90033,  United States; Not yet recruiting
      Duarte,  California,  91010,  United States; Not yet recruiting
      La Verne,  California,  91750,  United States; Not yet recruiting
      San Diego,  California,  92120,  United States; Recruiting
      Fountain Valley,  California,  92708,  United States; Not yet recruiting
      Fountain Valley,  California,  92708,  United States; Not yet recruiting
      Modesto,  California,  95355,  United States; Recruiting
      Sacramento,  California,  95819,  United States; Not yet recruiting
Colorado
      Colorado Springs,  Colorado,  80919,  United States; Not yet recruiting
District of Columbia
      Washington,  District of Columbia,  20010,  United States; Recruiting
Florida
      Gainesville,  Florida,  32610,  United States; Not yet recruiting
      Tampa,  Florida,  33612,  United States; Recruiting
      Tampa,  Florida,  33612,  United States; Not yet recruiting
Georgia
      Decatur,  Georgia,  30033,  United States; Recruiting
Iowa
      West Des Moines,  Iowa,  50265,  United States; Recruiting
Massachusetts
      Worcester,  Massachusetts,  01608,  United States; Recruiting
      Boston,  Massachusetts,  02115,  United States; Recruiting
      Boston,  Massachusetts,  02215,  United States; Recruiting
Michigan
      Ann Arbor,  Michigan,  48109,  United States; Recruiting
Nevada
      Reno,  Nevada,  89502,  United States; Recruiting
New Hampshire
      Lebanon,  New Hampshire,  37560,  United States; Not yet recruiting
New York
      Bethpage,  New York,  11714,  United States; Recruiting
North Carolina
      Durham,  North Carolina,  27710,  United States; Not yet recruiting
Oregon
      Portland,  Oregon,  97225,  United States; Recruiting
Pennsylvania
      Philadelphia,  Pennsylvania,  19111,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19140,  United States; Not yet recruiting
Tennessee
      Nashville,  Tennessee,  37232,  United States; Not yet recruiting
Texas
      Houston,  Texas,  77030,  United States; Recruiting
      Beaumont,  Texas,  77701,  United States; Recruiting
Virginia
      Richmond,  Virginia,  23249,  United States; Not yet recruiting
      Richmond,  Virginia,  23298,  United States; Not yet recruiting
      Norfolk,  Virginia,  23507,  United States; Recruiting
Washington
      Seattle,  Washington,  98104,  United States; Recruiting
      Tacoma,  Washington,  98405,  United States; Recruiting
Wisconsin
      Appleton,  Wisconsin,  54915,  United States; Not yet recruiting

Study ID Numbers:  767905/008
Record last reviewed:  January 2005
Last Updated:  January 18, 2005
Record first received:  January 18, 2005
ClinicalTrials.gov Identifier:  NCT00101998
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08