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ConstipationPhase 2NCT00101998

Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

A Phase 2 study testing alvimopan in people with Constipation and Bowel Dysfunction, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 162 sites in 26 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

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 subjects with cancer pain. The study will require five visits over a five-week period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Constipation, 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
233 participants
Where
162 sitesin 26 countries
Study dates
1 Oct 2003to 1 May 2006
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

  • Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.
  • Participant is taking opioid therapy for persistent cancer pain.
  • Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms [sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)].
  • Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.
  • Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.

Who cannot join

  • Participant is pregnant or lactating, or planning to become pregnant.
  • Participant is not ambulatory.
  • Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.
  • Participant is unable to eat, drink, take/hold down oral medications.
  • Participant is taking opioids for the management of drug addiction.
  • Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study.
Show all 11Show fewer
  • Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit.
  • Participant with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
  • Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.
  • Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.
  • Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.

Trial locations and contacts

162 sites in 26 countries.

162 sites in 26 countries

United States69 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87109

  • GSK Investigational Site

    Amarillo, Texas, 79106

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Baltimore, Maryland, 21218

  • GSK Investigational Site

    Baltimore, Maryland, 21229-5299

  • GSK Investigational Site

    Baltimore, Maryland, 21239

  • GSK Investigational Site

    Bethesda, Maryland, 20817

  • GSK Investigational Site

    Bethpage, New York, 11714

  • GSK Investigational Site

    Bismarck, North Dakota, 58501

  • GSK Investigational Site

    Bismarck, North Dakota, 58503

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Boston, Massachusetts, 02215

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Chicago, Illinois, 60610

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Denver, Colorado, 80210

  • GSK Investigational Site

    Duarte, California, 91010

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Flint, Michigan, 48503

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gainesville, Florida, 32604

  • GSK Investigational Site

    Hendersonville, North Carolina, 28793

  • GSK Investigational Site

    Hot Springs, Arkansas, 71913

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Huntington Station, New York, 11746

  • GSK Investigational Site

    Hutchinson, Kansas, 67502

  • GSK Investigational Site

    Inverness, Florida, 34452

  • GSK Investigational Site

    Jamaica, New York, 11432

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    La Verne, California, 91750

  • GSK Investigational Site

    Lecanto, Florida, 34461

  • GSK Investigational Site

    Los Angeles, California, 90057

  • GSK Investigational Site

    Los Gatos, California, 95032

  • GSK Investigational Site

    Miami Shores, Florida, 33138

  • GSK Investigational Site

    Middletown, Ohio, 45042

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    Modesto, California, 95355

  • GSK Investigational Site

    Nashville, Tennessee, 37232

  • GSK Investigational Site

    New Port Richey, Florida, 34652

  • GSK Investigational Site

    New Port Richey, Florida, 34653

  • GSK Investigational Site

    Norfolk, Virginia, 23507

  • GSK Investigational Site

    Ocala, Florida, 34474

  • GSK Investigational Site

    Palm Harbor, Florida, 34684

  • GSK Investigational Site

    Portland, Oregon, 97225

  • GSK Investigational Site

    Portsmouth, Virginia, 23704

  • GSK Investigational Site

    Raleigh, North Carolina, 27606

  • GSK Investigational Site

    Reno, Nevada, 89502

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Richmond, Virginia, 23298-5028

  • GSK Investigational Site

    Sacramento, California, 95819

  • GSK Investigational Site

    Saint Louis Park, Minnesota, 55426

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    Santa Monica, California, 90403

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stuart, Florida, 34996

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tampa, Florida, 33612-9497

  • GSK Investigational Site

    Titusville, Florida, 32796

  • GSK Investigational Site

    Tucson, Arizona, 85723

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010

  • GSK Investigational Site

    Webster, Texas, 77598

  • GSK Investigational Site

    West Des Moines, Iowa, 50265

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Worcester, Massachusetts, 01608

Other trials in United States

Canada13 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

    Lévis, Quebec, G6V 3Z1

  • GSK Investigational Site

    London, Ontario, N6A 4L6

  • GSK Investigational Site

    Montreal, Quebec, H1T 2M4

  • GSK Investigational Site

    North Bay, Ontario, P1B 2H3

  • GSK Investigational Site

    Oshawa, Ontario, L1G 2B9

  • GSK Investigational Site

    Québec, G1R 2J6

  • 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

Other trials in Canada

Spain12 sites

  • GSK Investigational Site

    Alcorcón, 28922

  • GSK Investigational Site

    Barcelona, 08023

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Granada, 18012

  • GSK Investigational Site

    Jaén, 23007

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Sabadell / Barcelona

  • GSK Investigational Site

    Serra / Valencia

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Soria, 42002

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

Italy11 sites

  • GSK Investigational Site

    Busca (CN), Piedmont, 12022

  • GSK Investigational Site

    Caserta, Campania, 81100

  • GSK Investigational Site

    Catania, Sicily, 95124

  • GSK Investigational Site

    Florence, Tuscany, 50139

  • GSK Investigational Site

    Forlì, Emilia-Romagna, 47100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Milan, Lombardy, 20127

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Novara, Piedmont, 28100

  • GSK Investigational Site

    Pavia, Lombardy, 27100

  • GSK Investigational Site

    Rimini, Emilia-Romagna, 47900

Other trials in Italy

Australia5 sites

  • GSK Investigational Site

    Daw Park, South Australia, 5041

  • GSK Investigational Site

    Malvern, Victoria, 3144

  • GSK Investigational Site

    Redcliffe, Queensland, 4020

  • GSK Investigational Site

    South Brisbane, Queensland, 4101

  • GSK Investigational Site

    St Leonards, New South Wales, 2065

Other trials in Australia

United Kingdom5 sites

  • GSK Investigational Site

    London, SW3 6JJ

  • GSK Investigational Site

    Newcastle upon Tyne, NE4 6BE

  • GSK Investigational Site

    Nottingham, NG5 1PB

  • GSK Investigational Site

    Sheffield, S10 2JF

  • GSK Investigational Site

    Surrey, SM2 5PT

Other trials in United Kingdom

Czechia4 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Brno, 656 91

  • GSK Investigational Site

    Pilsen, 304 60

  • GSK Investigational Site

    Prague, 100 34

Other trials in Czechia

Hungary4 sites

  • GSK Investigational Site

    Budapest, 1097

  • GSK Investigational Site

    Budapest, 1529

  • GSK Investigational Site

    Miskolc, 3529

  • GSK Investigational Site

    Zalaegerszeg-Pozva, 8900

Other trials in Hungary

Poland4 sites

  • GSK Investigational Site

    Bialystok, 15-540

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Otwock, 05-400

  • GSK Investigational Site

    Poznan, 60-569

Other trials in Poland

Russia4 sites

  • GSK Investigational Site

    Moscow, 117216

  • GSK Investigational Site

    Moscow, 119048

  • GSK Investigational Site

    Moscow, 127018

  • GSK Investigational Site

    St'Petersburg, 195247

Other trials in Russia

South Africa4 sites

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4001

  • GSK Investigational Site

    Groenkloof, Pretoria

  • GSK Investigational Site

    Houghton, Johannesburg, 2000

  • GSK Investigational Site

    Kenilworth, Cape Town, 7745

Other trials in South Africa

France3 sites

  • GSK Investigational Site

    Bordeaux, 33076

  • GSK Investigational Site

    Vandœuvre-lès-Nancy, 54511

  • GSK Investigational Site

    Villejuif, 94805

Other trials in France

Hong Kong3 sites

  • GSK Investigational Site

    Kwun Tong

  • GSK Investigational Site

    Pokfulam

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

New Zealand3 sites

  • GSK Investigational Site

    Dunedin, 9001

  • GSK Investigational Site

    Hastings, 4201

  • GSK Investigational Site

    Wellington, 6002

Other trials in New Zealand

Portugal3 sites

  • GSK Investigational Site

    Lisbon, 1069-166 Lisboa

  • GSK Investigational Site

    Lisbon, 1070

  • GSK Investigational Site

    Lisbon, 1800

Other trials in Portugal

Argentina2 sites

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1405CUB

  • GSK Investigational Site

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Germany2 sites

  • GSK Investigational Site

    Goslar, Lower Saxony, 38642

  • GSK Investigational Site

    Göttingen, Lower Saxony, 37073

Other trials in Germany

Peru2 sites

  • GSK Investigational Site

    Lima, Lima 11

  • GSK Investigational Site

    Lima, Lima 34

Other trials in Peru

South Korea2 sites

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 152-703

Other trials in South Korea

Finland1 site

  • GSK Investigational Site

    Helsinki, 00029

Other trials in Finland

India1 site

  • GSK Investigational Site

    Bangalore, 560 034

Other trials in India

Netherlands1 site

  • GSK Investigational Site

    Leeuwarden, 8934 AD

Other trials in Netherlands

Pakistan1 site

  • GSK Investigational Site

    Lahore, 54600

Other trials in Pakistan

Philippines1 site

  • GSK Investigational Site

    Manila, 1000

Other trials in Philippines

Taiwan1 site

  • GSK Investigational Site

    Taipei, 100

Other trials in Taiwan

Thailand1 site

  • GSK Investigational Site

    Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

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 subjects with cancer pain. The study will require five visits over a five-week period.

Being tested
alvimopan, placebo
Keywords
OBD (Induced Bowel Dysfunction), cancer pain, pain medication, constipation, bowel, bowel dysfunction
Medical subject headings
Constipation, Intestinal Diseases, Cancer 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 NCT00101998
Study groupRoleWhat they receive
Alvimopan 0.5 mg Twice Daily (BID)Experimental0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.
Receives: Drug: alvimopan
Alvimopan 1 mg Once Daily (QD)Experimental0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.
Receives: Drug: alvimopan; Drug: placebo
Alvimopan 1 mg Twice Daily (BID)Experimental0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.
Receives: Drug: alvimopan
PlaceboPlacebo comparatorPlacebo was administered orally BID for 3 weeks.
Receives: Drug: placebo

What is being measured

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

  1. Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.

Secondary outcomes (1)

  1. Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.

Timeline

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

  1. First posted19 Jan 2005 (estimated)
  2. Study start1 Oct 2003
  3. Primary completion1 May 2006
  4. Study completion1 May 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101998
Sponsor's protocol ID
3753-009
Other IDs
767905/008
Status last verified
Aug 2017
First submitted
18 Jan 2005
Last updated
30 Aug 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alvimopan in people with Constipation and Bowel Dysfunction, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 162 sites in 26 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 11 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 162 sites in United States, Canada, Spain, Italy, Australia and 21 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?

Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.. 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 NCT00101998.

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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