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Bowel DysfunctionPhase 3NCT00241722

Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

A Phase 3 study testing Alvimopan in people with Bowel Dysfunction and Constipation, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 227 sites in 17 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) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment… 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
805 participants
Where
227 sitesin 17 countries
Study dates
1 Aug 2005to 1 Feb 2007
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).

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.
  • Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.

Trial locations and contacts

227 sites in 17 countries.

227 sites in 17 countries

United States143 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87102

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Anaheim, California, 92805

  • GSK Investigational Site

    Arlington, Texas, 76017

  • GSK Investigational Site

    Arlington Heights, Illinois, 60005

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Bakersfield, California, 93311

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70808

  • GSK Investigational Site

    Bellingham, Washington, 98226

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Birmingham, Alabama, 35215

  • GSK Investigational Site

    Birmingham, Alabama, 35242

  • GSK Investigational Site

    Birmingham, Alabama, 35244

  • GSK Investigational Site

    Blackwood, New Jersey, 08012

  • GSK Investigational Site

    Bloomington, Illinois, 61701

  • GSK Investigational Site

    Boise, Idaho, 83702

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Brandon, Florida, 33511

  • GSK Investigational Site

    Brockton, Massachusetts, 02301

  • GSK Investigational Site

    Brownwood, Texas, 76801

  • GSK Investigational Site

    Buena Park, California, 90620

  • GSK Investigational Site

    Burbank, California, 91505

  • GSK Investigational Site

    Carnegie, Pennsylvania, 15106

  • GSK Investigational Site

    Centerville, Ohio, 45450

  • GSK Investigational Site

    Charleston, West Virginia, 25304

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Chaska, Minnesota, 55318

  • GSK Investigational Site

    Chattanooga, Tennessee, 37403

  • GSK Investigational Site

    Chicago, Illinois, 60610

  • GSK Investigational Site

    Chiefland, Florida, 32626

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cincinnati, Ohio, 45224

  • GSK Investigational Site

    Clarksville, Tennessee, 37043

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Clinton, Oklahoma, 73601

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Concord, North Carolina, 28025

  • GSK Investigational Site

    Dallas, Texas, 75218

  • GSK Investigational Site

    Dawsonville, Georgia, 30534

  • GSK Investigational Site

    Dayton, Ohio, 45408

  • GSK Investigational Site

    Dayton, Ohio, 45439

  • GSK Investigational Site

    Dayton, Ohio, 46432

  • GSK Investigational Site

    Deerfield Beach, Florida, 33441

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Dover, New Hampshire, 03820

  • GSK Investigational Site

    Edmonds, Washington, 98026

  • GSK Investigational Site

    Elizabeth, New Jersey, 07202

  • GSK Investigational Site

    Elkhart, Indiana, 46515

  • GSK Investigational Site

    Fort Myers, Florida, 33907

  • GSK Investigational Site

    Gainesville, Florida, 32607

  • GSK Investigational Site

    Glendale, Arizona, 85306

  • GSK Investigational Site

    Grand Blanc, Michigan, 48439

  • GSK Investigational Site

    Grand Prairie, Texas, 75052

  • GSK Investigational Site

    Greensboro, North Carolina, 27401

  • GSK Investigational Site

    Greensboro, North Carolina, 27403

  • GSK Investigational Site

    Henderson, Nevada, 89015

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Holly Hill, Florida, 32117

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Hot Springs, Arkansas, 71913

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Houston, Texas, 77090

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Indianapolis, Indiana, 46250

  • GSK Investigational Site

    Jupiter, Florida, 33458

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Lake Jackson, Texas, 77566

  • GSK Investigational Site

    Lake Success, New York, 11042

  • GSK Investigational Site

    Lancaster, Texas, 75146

  • GSK Investigational Site

    Las Vegas, Nevada, 89102

  • GSK Investigational Site

    Las Vegas, Nevada, 89103

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Little Rock, Arkansas, 72223

  • GSK Investigational Site

    Los Gatos, California, 95032

  • GSK Investigational Site

    Louisville, Kentucky, 40205

  • GSK Investigational Site

    Louisville, Kentucky, 40213

  • GSK Investigational Site

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Manchester, Missouri, 63021

  • GSK Investigational Site

    Marietta, Georgia, 30066

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Meridian, Idaho, 83642

  • GSK Investigational Site

    Miami, Florida, 33169

  • GSK Investigational Site

    Missoula, Montana, 59804

  • GSK Investigational Site

    Mobile, Alabama, 36606

  • GSK Investigational Site

    Muscle Shoals, Alabama, 35662

  • GSK Investigational Site

    Nixa, Missouri, 65714

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Northport, Alabama, 35476

  • GSK Investigational Site

    Ocala, Florida, 32607

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Olive Branch, Mississippi, 38654

  • GSK Investigational Site

    Omaha, Nebraska, 68114

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Oregon City, Oregon, 97045

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Ormond Beach, Florida, 32174

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Pasadena, Maryland, 21122

  • GSK Investigational Site

    Phoenix, Arizona, 85023

  • GSK Investigational Site

    Phoenix, Arizona, 85029

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Pismo Beach, California, 93449

  • 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

    Rockford, Illinois, 61107

  • GSK Investigational Site

    Rockville, Maryland, 20852

  • GSK Investigational Site

    Saint Cloud, Florida, 34769

  • GSK Investigational Site

    Salt Lake City, Utah, 84106

  • GSK Investigational Site

    Salt Lake City, Utah, 84120

  • GSK Investigational Site

    San Antonio, Texas, 78238

  • GSK Investigational Site

    San Diego, California, 92108

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Diego, California, 92121

  • GSK Investigational Site

    Scottsdale, Arizona, 85251

  • GSK Investigational Site

    Scottsdale, Arizona, 85258

  • GSK Investigational Site

    Shreveport, Louisiana, 71103

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    St Louis, Missouri, 63108

  • GSK Investigational Site

    Stockbridge, Georgia, 30281

  • GSK Investigational Site

    Stratford, Connecticut, 6497

  • GSK Investigational Site

    Sun City, Arizona, 85351

  • GSK Investigational Site

    Suwanee, Georgia, 30024

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tempe, Arizona, 85282

  • GSK Investigational Site

    Torrance, California, 90503

  • GSK Investigational Site

    Traverse City, Michigan, 49684

  • GSK Investigational Site

    Trumbull, Connecticut, 06611

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Virginia Beach, Virginia, 23452

  • GSK Investigational Site

    Vista, California, 92083

  • GSK Investigational Site

    Wellesley Hills, Massachusetts, 02481

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Woonsocket, Rhode Island, 02895

Other trials in United States

Canada29 sites

  • GSK Investigational Site

    Bonaventure, Quebec, G0C 1E0

  • GSK Investigational Site

    Brampton, Ontario, L6T 3J1

  • GSK Investigational Site

    Calgary, Alberta, T3C 3P1

  • GSK Investigational Site

    Chandler, Quebec, G0C 1K0

  • GSK Investigational Site

    Charlottetown, Prince Edward Island, C1A 8T5

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3P4

  • GSK Investigational Site

    Drummondville, Quebec, J2B 1H8

  • GSK Investigational Site

    Edmonton, Alberta, T5A 4L8

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Halifax, Nova Scotia, B3K 5R3

  • GSK Investigational Site

    Hamilton, Ontario, L8L 5G8

  • GSK Investigational Site

    Kelowna, British Columbia, V1Y 2H4

  • GSK Investigational Site

    Kitchener, Ontario, N2M 5N6

  • GSK Investigational Site

    Langley, British Columbia, V3A 4H9

  • GSK Investigational Site

    Mirabel, Quebec, J7J 2K8

  • GSK Investigational Site

    Mississauga, Ontario, L4T 4J2

  • GSK Investigational Site

    Moncton, New Brunswick, E1G 1A7

  • GSK Investigational Site

    Montreal, Quebec, H3M 3A9

  • 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

    Sherbrooke, Quebec, J1H 1Z1

  • GSK Investigational Site

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

  • GSK Investigational Site

    Toronto, Ontario, M3H 5S4

  • GSK Investigational Site

    Toronto, Ontario, M3J 1N2

  • GSK Investigational Site

    Toronto, Ontario, M3N 2V7

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8Z 1Y2

  • GSK Investigational Site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

United Kingdom11 sites

  • GSK Investigational Site

    Bexhill-on-Sea, East Sussex, TN39 4SP

  • GSK Investigational Site

    Cardiff, Glamorgan, CF14 9BB

  • GSK Investigational Site

    Coventry, Warwickshire, CV6 4DD

  • GSK Investigational Site

    Glasgow, Lanarkshire, G3 8YJ

  • GSK Investigational Site

    Glasgow, Lanarkshire, G69 7AD

  • GSK Investigational Site

    Leeds, LS14 6UH

  • GSK Investigational Site

    London, EC1A 7BE

  • GSK Investigational Site

    Reading, Berkshire, RG7 3SQ

  • GSK Investigational Site

    Slough, Berkshire, SL2 1HD

  • GSK Investigational Site

    Sunbury-on-Thames, Middlesex, TW16 6RH

  • GSK Investigational Site

    Yaxley, Peterborough, PE7 3JL

Other trials in United Kingdom

Australia10 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

    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

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

Hong Kong4 sites

  • GSK Investigational Site

    Kowloon

  • GSK Investigational Site

    Kwun Tong

  • GSK Investigational Site

    Pokfulam

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

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

Poland3 sites

  • GSK Investigational Site

    Gdansk, 80-952

  • GSK Investigational Site

    Krakow, 31-531

  • GSK Investigational Site

    Wroclaw, 50-368

Other trials in Poland

Taiwan3 sites

  • GSK Investigational Site

    Tainan, 704

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 114

Other trials in Taiwan

Austria2 sites

  • GSK Investigational Site

    Vienna, A-1100

  • GSK Investigational Site

    Vienna, A-1130

Other trials in Austria

Netherlands2 sites

  • GSK Investigational Site

    Roosendaal, 4708 AE

  • GSK Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

Denmark1 site

  • GSK Investigational Site

    Ishøj, 2635

Other trials in Denmark

Finland1 site

  • GSK Investigational Site

    Helsinki, 00029

Other trials in Finland

Hungary1 site

  • GSK Investigational Site

    Budapest, 1083

Other trials in Hungary

Ireland1 site

  • GSK Investigational Site

    Cork

Other trials in Ireland

Switzerland1 site

  • GSK Investigational Site

    Bern, 3011

Other trials in Switzerland

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months 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) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

Being tested
Alvimopan, Placebo
Keywords
bowel dysfunction, constipation, gastrointestinal, opioids, pain, non-cancer pain, opioid-induced
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.

  • AlvimopanDrug

  • PlaceboDrug

Study groups in NCT00241722
Study groupRoleWhat they receive
Alvimopan 0.5 mg Twice Daily (BID)Experimental0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
Receives: Drug: Alvimopan
PlaceboPlacebo comparatorPlacebo was administered orally BID for 12 months.
Receives: Drug: Placebo

What is being measured

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

  1. To compare alvimopan with placebo for long-term safety and tolerability

    Measured: 12 months

Secondary outcomes (1)

  1. Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)

    Measured: 12 months

Timeline

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

  1. First posted19 Oct 2005 (estimated)
  2. Study start1 Aug 2005
  3. Primary completion1 Feb 2007
  4. Study completion1 Feb 2007

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
805 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00241722
Sponsor's protocol ID
3753-013
Other IDs
SB-767905/014
Status last verified
Aug 2017
First submitted
17 Oct 2005
Last updated
30 Aug 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alvimopan in people with Bowel Dysfunction and Constipation, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 227 sites in 17 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 5 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in United States, Canada, United Kingdom, Australia, Spain and 12 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 long-term safety and tolerability (time frame: 12 months). 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 NCT00241722.

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 30 Aug 2017.

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