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Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid

Primary Purpose

Cancer, Constipation

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
alvimopan
Placebo
Alvimopan 0.5 mg/day
Alvimopan 1 mg/day
Sponsored by
Cubist Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Opioids, cancer, constipation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Have cancer. Taking opioid therapy for continued intractable pain. Experiencing less bowel movement frequency compared to that before the opioid treatment. Must meet the protocol-definition of opioid-induced constipation. Exclusion criteria: Gastrointestinal or pelvic disorders known to affect gastrointestinal functions or induce bowel transit disorder and ileus. Subjects, who in the investigator's opinion, have gastrointestinal dysfunction predominantly due to causes other than the use of opioids.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    Alvimopan 0.25 mg/yday

    Alviompan 0.5 mg/day

    Alvimopan 1 mg/day

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period

    Secondary Outcome Measures

    Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire

    Full Information

    First Posted
    May 26, 2006
    Last Updated
    September 1, 2015
    Sponsor
    Cubist Pharmaceuticals LLC
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00331045
    Brief Title
    Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid
    Official Title
    Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-controlled Double-blind Study in Cancer Patients-
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Terminated
    Why Stopped
    Subject registration did not proceed as expected; difficult to complete within scheduled time frame; prematurely terminated w/ 21 subjects randomized.
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cubist Pharmaceuticals LLC
    Collaborators
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer, Constipation
    Keywords
    Opioids, cancer, constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Alvimopan 0.25 mg/yday
    Arm Type
    Experimental
    Arm Title
    Alviompan 0.5 mg/day
    Arm Type
    Experimental
    Arm Title
    Alvimopan 1 mg/day
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    alvimopan
    Other Intervention Name(s)
    SB767905
    Intervention Description
    0.25 mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Alvimopan 0.5 mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Alvimopan 1 mg/day
    Primary Outcome Measure Information:
    Title
    Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period
    Secondary Outcome Measure Information:
    Title
    Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Have cancer. Taking opioid therapy for continued intractable pain. Experiencing less bowel movement frequency compared to that before the opioid treatment. Must meet the protocol-definition of opioid-induced constipation. Exclusion criteria: Gastrointestinal or pelvic disorders known to affect gastrointestinal functions or induce bowel transit disorder and ileus. Subjects, who in the investigator's opinion, have gastrointestinal dysfunction predominantly due to causes other than the use of opioids.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials, MD
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid

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