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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00331045
Recruitment Status : Terminated (Subject registration did not proceed as expected; difficult to complete within scheduled time frame; prematurely terminated w/ 21 subjects randomized.)
First Posted : May 29, 2006
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Constipation Drug: alvimopan Drug: Placebo Drug: Alvimopan 0.5 mg/day Drug: Alvimopan 1 mg/day Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Alvimopan

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: Alvimopan 0.25 mg/yday Drug: alvimopan
0.25 mg/day
Other Name: SB767905
Experimental: Alviompan 0.5 mg/day Drug: Alvimopan 0.5 mg/day
Experimental: Alvimopan 1 mg/day Drug: Alvimopan 1 mg/day


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331045


Sponsors and Collaborators
Cubist Pharmaceuticals LLC
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information
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Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00331045    
Other Study ID Numbers: ABD102965
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2009
Keywords provided by Cubist Pharmaceuticals LLC:
Opioids
cancer
constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Alvimopan
Gastrointestinal Agents