CancerPhase 2NCT00135577
Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
A Phase 2 study testing alvimopan in people with Cancer and Bowel Dysfunction, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 40 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Bowel Dysfunction
- What is being tested?
- alvimopan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 40 sitesin 13 countries
- Study dates
- Sep 2004to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 13 countries.
40 sites in 13 countries
United States14 sites
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Duarte, California, 91010
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Hendersonville, North Carolina, 28793
GSK Investigational Site
La Verne, California, 91750
GSK Investigational Site
New Port Richey, Florida, 34652
GSK Investigational Site
Sacramento, California, 95819
GSK Investigational Site
San Diego, California, 92103
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tampa, Florida, 33612-9497
GSK Investigational Site
West Des Moines, Iowa, 50265
GSK Investigational Site
Worcester, Massachusetts, 01608
Canada7 sites
GSK Investigational Site
Bonaventure, Quebec, G0C 1E0
GSK Investigational Site
Chandler, Quebec, G0C 1K0
GSK Investigational Site
Greater Sudbury, Ontario, P3E 5J1
GSK Investigational Site
Kitchener, Ontario, N2G 1G3
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6
GSK Investigational Site
Winnipeg, Manitoba, R3A 1R9
Poland5 sites
GSK Investigational Site
Bialystok, 15-540
GSK Investigational Site
Lublin, 20-090
GSK Investigational Site
Olsztyn, 10-228
GSK Investigational Site
Otwock, 05-400
GSK Investigational Site
Poznan, 60-569
France4 sites
GSK Investigational Site
Bordeaux, 33076
GSK Investigational Site
Strasbourg, 67000
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511
GSK Investigational Site
Villejuif, 94805
Portugal2 sites
GSK Investigational Site
Lisbon, 1070
GSK Investigational Site
Lisbon, 1800
About this study
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 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.
- Conditions
- Cancer, Bowel Dysfunction
- Being tested
- alvimopan, placebo
- Keywords
- opioids, constipation, opioid-induced bowel dysfunction
- Medical subject headings
- Neoplasms, Intestinal Diseases, Constipation, Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alvimopanDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Alvimopan 0.5 mg Twice Daily (BID) | Experimental | 0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening. Receives: Drug: alvimopan |
| Alvimopan 1 mg Once Daily (QD) | Experimental | 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. Receives: Drug: alvimopan; Drug: placebo |
| Alvimopan 1 mg Twice Daily (BID) | Experimental | 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. Receives: Drug: alvimopan |
| Placebo | Placebo comparator | Placebo was administered orally once in the morning and once in evening. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of reported adverse events, including serious adverse events
Secondary outcomes (1)
Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135577
- Sponsor's protocol ID
- ABD101684
- Status last verified
- Sep 2009
- First submitted
- 24 Aug 2005
- Last updated
- 2 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00135577
- Acronym / sponsor ID
- ABD101684
- Conditions
- Cancer, Bowel Dysfunction
- Keywords
- opioids, constipation, opioid-induced bowel dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 26 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alvimopan 0.5 mg Twice Daily (BID) | Experimental | Drug: alvimopan0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening. |
| Alvimopan 1 mg Once Daily (QD) | Experimental | Drug: alvimopan, Drug: placeboParticipants 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. |
| Alvimopan 1 mg Twice Daily (BID) | Experimental | Drug: alvimopanParticipants 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. |
| Placebo | Placebo comparator | Drug: placeboPlacebo was administered orally once in the morning and once in evening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alvimopan | Drug | Alvimopan 0.5 mg Twice Daily (BID), Alvimopan 1 mg Once Daily (QD), Alvimopan 1 mg Twice Daily (BID) |
| placebo | Drug | Alvimopan 1 mg Once Daily (QD), Placebo |
Primary outcome
Incidence of reported adverse events, including serious adverse events
1 secondary outcome
Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
40 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alvimopan in people with Cancer and Bowel Dysfunction, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 40 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Canada, Poland, France, Portugal and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of reported adverse events, including serious adverse events. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.