Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
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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: NCT00135577 |
Recruitment Status :
Completed
First Posted : August 26, 2005
Last Update Posted : September 2, 2015
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Study SB-767905/008 was 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 participants with cancer pain.
Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Bowel Dysfunction | Drug: alvimopan Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening.
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Drug: alvimopan |
Experimental: Alvimopan 1 mg Once Daily (QD)
Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg in the morning and received placebo in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan in the morning and placebo in the evening for 3 days, then 1 mg of alvimopan in the morning and placebo in the evening for the remaining 3 weeks. |
Drug: alvimopan Drug: placebo |
Experimental: Alvimopan 1 mg Twice Daily (BID)
Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg once in the morning and once in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan once in the morning and once in the evening for 3 days, then 1 mg of alvimopan once in the morning and once in the evening. |
Drug: alvimopan |
Placebo Comparator: Placebo
Placebo was administered orally once in the morning and once in evening.
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Drug: placebo |
- Incidence of reported adverse events, including serious adverse events
- Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Completed GSK sponsored alvimopan (opioid-induced bowel dysfunction) OBD study for subjects with cancer-related pain, e.g. SB-767905/008.
- Taking full agonist opioid therapy for cancer related pain.
- Met entry criteria of OBD in original study and per investigator continues to require therapy for management of OBD.
- Capable of completing paper questionnaires at the study visits.
Exclusion Criteria:
- Unable to eat or drink.
- Taking opioids for management of drug addiction.
- Unable to use only rescue laxatives provided.
- Inappropriately managed severe constipation that puts subject at risk of complications.
- Has gastrointestinal (GI) or pelvic disorder known to affect bowel transit.
- Concomitant medication(s), medical condition, or clinically significant laboratory abnormality that could jeopardize subject and also contraindicate study participation.

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): NCT00135577
United States, California | |
GSK Investigational Site | |
Duarte, California, United States, 91010 | |
GSK Investigational Site | |
Fountain Valley, California, United States, 92708 | |
GSK Investigational Site | |
La Verne, California, United States, 91750 | |
GSK Investigational Site | |
Sacramento, California, United States, 95819 | |
GSK Investigational Site | |
San Diego, California, United States, 92103 | |
United States, Florida | |
GSK Investigational Site | |
New Port Richey, Florida, United States, 34652 | |
GSK Investigational Site | |
Tampa, Florida, United States, 33612-9497 | |
United States, Iowa | |
GSK Investigational Site | |
West Des Moines, Iowa, United States, 50265 | |
United States, Massachusetts | |
GSK Investigational Site | |
Boston, Massachusetts, United States, 02215 | |
GSK Investigational Site | |
Worcester, Massachusetts, United States, 01608 | |
United States, Missouri | |
GSK Investigational Site | |
St. Louis, Missouri, United States, 63141 | |
United States, North Carolina | |
GSK Investigational Site | |
Durham, North Carolina, United States, 27710 | |
GSK Investigational Site | |
Hendersonville, North Carolina, United States, 28793 | |
United States, Washington | |
GSK Investigational Site | |
Tacoma, Washington, United States, 98405 | |
Canada, Manitoba | |
GSK Investigational Site | |
Winnipeg, Manitoba, Canada, R3A 1R9 | |
Canada, Newfoundland and Labrador | |
GSK Investigational Site | |
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
Canada, Ontario | |
GSK Investigational Site | |
Kitchener, Ontario, Canada, N2G 1G3 | |
GSK Investigational Site | |
Sudbury, Ontario, Canada, P3E 5J1 | |
Canada, Quebec | |
GSK Investigational Site | |
Bonaventure, Quebec, Canada, G0C 1E0 | |
GSK Investigational Site | |
Chandler, Quebec, Canada, G0C 1K0 | |
GSK Investigational Site | |
Sherbrooke, Quebec, Canada, J1H 1Z1 | |
Finland | |
GSK Investigational Site | |
Helsinki, Finland, 00029 | |
France | |
GSK Investigational Site | |
Bordeaux Cedex, France, 33076 | |
GSK Investigational Site | |
Strasbourg, France, 67000 | |
GSK Investigational Site | |
Vandoeuvre-Les-Nancy, France, 54511 | |
GSK Investigational Site | |
Villejuif Cedex, France, 94805 | |
Hong Kong | |
GSK Investigational Site | |
Kwun Tong, Hong Kong | |
New Zealand | |
GSK Investigational Site | |
Wellington, New Zealand, 6002 | |
Pakistan | |
GSK Investigational Site | |
Lahore, Pakistan, 54600 | |
Peru | |
GSK Investigational Site | |
Lima, Peru, Lima 34 | |
Poland | |
GSK Investigational Site | |
Bialystok, Poland, 15-540 | |
GSK Investigational Site | |
Lublin, Poland, 20-090 | |
GSK Investigational Site | |
Olsztyn, Poland, 10-228 | |
GSK Investigational Site | |
Otwock, Poland, 05-400 | |
GSK Investigational Site | |
Poznan, Poland, 60-569 | |
Portugal | |
GSK Investigational Site | |
Lisboa, Portugal, 1070 | |
GSK Investigational Site | |
Lisboa, Portugal, 1800 | |
Russian Federation | |
GSK Investigational Site | |
Moscow, Russian Federation, 117216 | |
Spain | |
GSK Investigational Site | |
Alcorcon, Spain, 28922 | |
United Kingdom | |
GSK Investigational Site | |
Nottingham, United Kingdom, NG5 1PB |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | Cubist Pharmaceuticals LLC |
ClinicalTrials.gov Identifier: | NCT00135577 |
Other Study ID Numbers: |
ABD101684 |
First Posted: | August 26, 2005 Key Record Dates |
Last Update Posted: | September 2, 2015 |
Last Verified: | September 2009 |
opioids constipation opioid-induced bowel dysfunction |
Intestinal Diseases Gastrointestinal Diseases Cancer Pain Pain |
Neurologic Manifestations Digestive System Diseases Alvimopan Gastrointestinal Agents |