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Bowel DysfunctionPhase 3NCT00259922

Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

A Phase 3 study testing Alvimopan and Alviompan in people with Bowel Dysfunction and Constipation, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 187 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bowel Dysfunction, Constipation
What is being tested?
Alvimopan and Alviompan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
485 participants
Where
187 sitesin 12 countries
Study dates
Aug 2005to Jun 2006
Phase
Phase 3
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

  • Consented to participate in this study.
  • Taking opioid therapy for persistent non-cancer pain.
  • Has bowel dysfunction mainly due to opioids.
  • Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
  • Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).
  • Willing to report daily bowel symptoms.

Who cannot join

  • Pregnant, lactating, or planning to become pregnant.
  • Not ambulatory.
  • Participated in another trial with an investigational drug in the past 30 days.
  • Taking opioids for the management of drug addiction or cancer-related pain.
  • Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
  • Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
  • HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.

Trial locations and contacts

187 sites in 12 countries.

187 sites in 12 countries

United States119 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87102

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Atlanta, Georgia, 30338

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Austin, Texas, 78756

  • GSK Investigational Site

    Bakersfield, California, 93311

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Birmingham, Alabama, 35215

  • GSK Investigational Site

    Birmingham, Alabama, 35216

  • GSK Investigational Site

    Blackwood, New Jersey, 08012

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Brockton, Massachusetts, 02301

  • GSK Investigational Site

    Centerville, Ohio, 45450

  • GSK Investigational Site

    Charleston, West Virginia, 25304

  • GSK Investigational Site

    Chicago, Illinois, 60610

  • GSK Investigational Site

    Chiefland, Florida, 32626

  • GSK Investigational Site

    Cincinnati, Ohio, 45236

  • GSK Investigational Site

    Clearwater, Florida, 33761

  • GSK Investigational Site

    Corpus Christi, Texas, 78404

  • GSK Investigational Site

    Cranston, Rhode Island, 02920

  • GSK Investigational Site

    Cumming, Georgia, 30040

  • GSK Investigational Site

    Dayton, Ohio, 46432

  • GSK Investigational Site

    Deerfield Beach, Florida, 33441

  • GSK Investigational Site

    Destin, Florida, 32541

  • GSK Investigational Site

    Dover, New Hampshire, 03820

  • GSK Investigational Site

    Egg Harbor, New Jersey, 08234

  • GSK Investigational Site

    Eugene, Oregon, 97401

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fort Myers, Florida, 33916

  • GSK Investigational Site

    Galveston, Texas, 77555-0188

  • GSK Investigational Site

    Greensboro, North Carolina, 27403

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Hollywood, Florida, 33023

  • GSK Investigational Site

    Houston, Texas, 77070

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Independence, Missouri, 64055

  • GSK Investigational Site

    Indianapolis, Indiana, 46250

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    La Crosse, Wisconsin, 54601

  • GSK Investigational Site

    Largo, Florida, 33770

  • GSK Investigational Site

    Las Vegas, Nevada, 89102

  • GSK Investigational Site

    Las Vegas, Nevada, 89103

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Las Vegas, Nevada, 89146

  • GSK Investigational Site

    Levittown, Pennsylvania, 19056

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    Libertyville, Illinois, 60048

  • GSK Investigational Site

    Long Beach, California, 90813

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Los Gatos, California, 95032

  • GSK Investigational Site

    Louisville, Kentucky, 40205

  • GSK Investigational Site

    Margate, Florida, 33063

  • GSK Investigational Site

    Marietta, Georgia, 30066

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Meridian, Idaho, 83642

  • GSK Investigational Site

    Mesa, Arizona, 85205

  • GSK Investigational Site

    Miami, Florida, 33138

  • GSK Investigational Site

    Miami, Florida, 33155

  • GSK Investigational Site

    Miami, Florida, 33169

  • GSK Investigational Site

    Mineola, New York, 11501

  • GSK Investigational Site

    Missoula, Montana, 59804

  • GSK Investigational Site

    Mobile, Alabama, 36606

  • GSK Investigational Site

    New Tazewell, Tennessee, 37824-1409

  • GSK Investigational Site

    New York, New York, 10022

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Northport, Alabama, 35476

  • GSK Investigational Site

    Northridge, California, 91325

  • GSK Investigational Site

    Oak Forest, Illinois, 60452

  • GSK Investigational Site

    Oakbrook Terrace, Illinois, 60181

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Olive Branch, Mississippi, 38654

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Ormond Beach, Florida, 32174

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Pasadena, California, 91105

  • GSK Investigational Site

    Pasadena, Maryland, 21122

  • GSK Investigational Site

    Perrysburg, Ohio, 43551

  • GSK Investigational Site

    Phoenix, Arizona, 85029

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15243

  • GSK Investigational Site

    Portage, Michigan, 49024

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Reading, Pennsylvania, 19611

  • GSK Investigational Site

    Richardson, Texas, 75080

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Rochester, New York, 14627

  • GSK Investigational Site

    Rockville, Maryland, 20852

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    Saint Cloud, Florida, 34769

  • GSK Investigational Site

    Salem, Oregon, 97301

  • GSK Investigational Site

    Salt Lake City, Utah, 84107

  • GSK Investigational Site

    San Antonio, Texas, 78217

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92108

  • GSK Investigational Site

    San Rafael, California, 94901

  • GSK Investigational Site

    Santa Ana, California, 92704

  • GSK Investigational Site

    Scottsdale, Arizona, 85251

  • GSK Investigational Site

    Scottsdale, Arizona, 85258

  • GSK Investigational Site

    Spokane, Washington, 99207

  • GSK Investigational Site

    St Louis, Missouri, 63108

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stamford, Connecticut, 06905

  • GSK Investigational Site

    Stockbridge, Georgia, 30281

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Tempe, Arizona, 85282

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20003

  • GSK Investigational Site

    Waterbury, Connecticut, 06708

  • GSK Investigational Site

    Waterford, Michigan, 48327

  • GSK Investigational Site

    Wellesley Hills, Massachusetts, 02481

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Winterhaven, Florida, 33880

  • GSK Investigational Site

    Yakima, Washington, 98902

Other trials in United States

Australia12 sites

  • GSK Investigational Site

    Bedford Park, South Australia, 5042

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Broadmeadow, New South Wales, 2292

  • GSK Investigational Site

    Carina Heights, Queensland, 4152

  • GSK Investigational Site

    Carlton, Victoria, 3053

  • GSK Investigational Site

    Fremantle, Western Australia, 6160

  • GSK Investigational Site

    Kippa-Ring, Queensland, 4021

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Newcastle, New South Wales, 2300

  • GSK Investigational Site

    Port Lincoln, South Australia, 5606

  • GSK Investigational Site

    St Leonards, New South Wales, 2065

  • GSK Investigational Site

    Toorak Gardens, South Australia, 5065

Other trials in Australia

Canada11 sites

  • GSK Investigational Site

    Bonaventure, Quebec, G0C 1E0

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3V9

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3A 1Y8

  • GSK Investigational Site

    Mississauga, Ontario, L4T 4J2

  • GSK Investigational Site

    Moncton, New Brunswick, E1G 1A7

  • GSK Investigational Site

    North Bay, Ontario, P1B 2H3

  • GSK Investigational Site

    North York, Ontario, M2M 4E7

  • GSK Investigational Site

    Saint Romuald, Quebec, G6W 5M6

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1E 2C2

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8Z 1Y2

  • GSK Investigational Site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

South Africa8 sites

  • GSK Investigational Site

    Athlone, Cape Town, 7760

  • GSK Investigational Site

    Erasmuskloof, Pretoria, 0048

  • GSK Investigational Site

    Fourways, Johannesburg

  • GSK Investigational Site

    Kempton Park, 1620

  • GSK Investigational Site

    Kenilworth, Cape Town, 7708

  • GSK Investigational Site

    Lynnwood, Pretoria, 0040

  • GSK Investigational Site

    Tygervalley, 7536

  • GSK Investigational Site

    Westridge, Mitchells Plain, 7798

Other trials in South Africa

Spain8 sites

  • GSK Investigational Site

    Alcorcón, 28922

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Ferrol

  • GSK Investigational Site

    Granada, 18012

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Valencia, 46014

Other trials in Spain

France6 sites

  • GSK Investigational Site

    Boulogne, 92100

  • GSK Investigational Site

    Grenoble, 38000

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Paris, 75010

  • GSK Investigational Site

    Paris, 75012

  • GSK Investigational Site

    Paris, 75181

Other trials in France

Netherlands5 sites

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Breda, 4819 EV

  • GSK Investigational Site

    Roosendaal, 4708 AE

  • GSK Investigational Site

    Rotterdam, 3083 AN

  • GSK Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

Norway5 sites

  • GSK Investigational Site

    Oslo, N-0027

  • GSK Investigational Site

    Oslo, N-0260

  • GSK Investigational Site

    Paradis, 5231

  • GSK Investigational Site

    Rådahl, 5235

  • GSK Investigational Site

    Skien, N-3710

Other trials in Norway

Hungary4 sites

  • GSK Investigational Site

    Budapest, 1083

  • GSK Investigational Site

    Budapest, 1183

  • GSK Investigational Site

    Csongrád, 6640

  • GSK Investigational Site

    Heves, 3360

Other trials in Hungary

Sweden4 sites

  • GSK Investigational Site

    Jönköping, SE-551 85

  • GSK Investigational Site

    Karlstad, SE-651 85

  • GSK Investigational Site

    Linköping, SE-581 85

  • GSK Investigational Site

    Stockholm, SE-141 86

Other trials in Sweden

New Zealand3 sites

  • GSK Investigational Site

    Christchurch

  • GSK Investigational Site

    Hamilton, 2001

  • GSK Investigational Site

    Tauranga, 3001

Other trials in New Zealand

Switzerland2 sites

  • GSK Investigational Site

    Bern, 3011

  • GSK Investigational Site

    Nottwil, 6207

Other trials in Switzerland

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

Being tested
Placebo, Alvimopan, Alviompan
Keywords
constipation, gastrointestinal, opioids, pain, non-cancer pain, opioid-induced, bowel dysfunction
Medical subject headings
Intestinal Diseases, Constipation, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo

  • AlvimopanDrug

    Also called Entereg

    0.5 mg QD

  • AlviompanDrug

    Also called Entereg

    0.5 mg BID

Study groups in NCT00259922
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Alvimopan 0.5 mg once dailyExperimental0.5 mg once daily (QD)
Receives: Drug: Alvimopan
Alvimopan 0.5 mg twice dailyExperimental0.5 mg twice daily (BID)
Receives: Drug: Alviompan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare alvimopan with placebo for efficacy in the treatment of OBD

Secondary outcomes (1)

  1. Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionJun 2006

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00259922
Sponsor's protocol ID
SB-767905/013
Status last verified
Sep 2009
First submitted
29 Nov 2005
Last updated
2 Sep 2015
Results posted
No

Publications

  • Irving G, Penzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):175-84. doi: 10.1016/j.jpain.2010.06.013.

    PubMed 21292168

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alvimopan and Alviompan in people with Bowel Dysfunction and Constipation, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 187 sites in 12 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 6 inclusion and 7 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 187 sites in United States, Australia, Canada, South Africa, Spain and 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

To compare alvimopan with placebo for efficacy in the treatment of OBD. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00259922, which also lists 1 linked publication.

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.

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