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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

Phase 2
18 Years
Not Enrolling
Constipation, Bowel Dysfunction

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

Inclusion 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.

- Subject meets the definition of opioid-induced bowel dysfunction as follows: Since
starting opioid therapy, the subject has had decreased 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2003

Completion Date:

Related Keywords:

  • Constipation
  • Bowel Dysfunction
  • OBD (Induced Bowel Dysfunction)
  • cancer pain
  • pain medication
  • constipation
  • bowel
  • bowel dysfunction
  • Constipation
  • Intestinal Diseases
  • Gastrointestinal Diseases



GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteLittle Rock, Arkansas  72205
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteAlbuquerque, New Mexico  87109
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteFargo, North Dakota  58103
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteWashington, District of Columbia  20307-5001
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteHenderson, Nevada  89014
GSK Investigational SiteOregon City, Oregon  97045
GSK Investigational SiteSeattle, Washington  98133