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

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

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
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 |
Opioids cancer constipation |
Constipation Signs and Symptoms, Digestive Alvimopan Gastrointestinal Agents |