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.

Country

City, postcode or hospital

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

Conditions: Bowel Dysfunction, Constipation
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 group	Role	What they receive
Alvimopan 0.5 mg Twice Daily (BID)	Experimental	0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months. Receives: Drug: Alvimopan
Placebo	Placebo comparator	Placebo 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.

To compare alvimopan with placebo for long-term safety and tolerability
Measured: 12 months

Secondary outcomes (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 Aug 20051 Feb 2007

First posted19 Oct 2005 (estimated)
Study start1 Aug 2005
Primary completion1 Feb 2007
Study completion1 Feb 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bowel DysfunctionStudies 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 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00241722
Acronym / sponsor ID: 3753-013
Conditions: Bowel Dysfunction, Constipation
Keywords: bowel dysfunction, constipation, gastrointestinal, opioids, pain, non-cancer pain, opioid-induced
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 805 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: 1 Aug 2005 (actual)
Primary completion: 1 Feb 2007 (actual)
Study completion: 1 Feb 2007 (actual)
First posted: 19 Oct 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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Alvimopan 0.5 mg Twice Daily (BID)	Experimental	Drug: Alvimopan0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
Placebo	Placebo comparator	Drug: PlaceboPlacebo was administered orally BID for 12 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (7 listed)

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.

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)
Placebo	Drug	Placebo

Primary outcome

To compare alvimopan with placebo for long-term safety and tolerability
Time frame: 12 months

1 secondary outcome

Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)
Time frame: 12 months

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 30 Aug 2017.

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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

227 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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; AzTrials last refreshed its copy on 8 Nov 2026.