Bowel DysfunctionPhase 3NCT00256932
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 200 sites in 10 countries.
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 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 200 sitesin 10 countries
- Study dates
- Aug 2005to May 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
- Has 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
200 sites in 10 countries.
200 sites in 10 countries
United States137 sites
GSK Investigational Site
Alexandria, Virginia, 22304
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Anaheim, California, 92805
GSK Investigational Site
Arlington, Texas, 76017
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
GSK Investigational Site
Baltimore, Maryland, 21229-5299
GSK Investigational Site
Bellingham, Washington, 98226
GSK Investigational Site
Beuna Park, California, 90620
GSK Investigational Site
Birmingham, Alabama, 35243
GSK Investigational Site
Birmingham, Alabama, 35244
GSK Investigational Site
Bloomington, Illinois, 61701
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Brandon, Florida, 33511
GSK Investigational Site
Brooksville, Florida, 34613
GSK Investigational Site
Brownwood, Texas, 76801
GSK Investigational Site
Burbank, California, 91505
GSK Investigational Site
Calera, Alabama, 35040
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Charlotte, North Carolina, 28204
GSK Investigational Site
Charlotte, North Carolina, 28210
GSK Investigational Site
Chaska, Minnesota, 55318
GSK Investigational Site
Chesapeake, Virginia, 23322
GSK Investigational Site
Christiansburg, Virginia, 24073
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Cincinnati, Ohio, 45224
GSK Investigational Site
Colleyville, Texas, 76034
GSK Investigational Site
Columbus, Ohio, 43215
GSK Investigational Site
Concord, North Carolina, 28025
GSK Investigational Site
Danville, Virginia, 24541
GSK Investigational Site
Dawsonville, Georgia, 30534
GSK Investigational Site
Dayton, Ohio, 45408
GSK Investigational Site
Dayton, Ohio, 45439
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
Decatur, Georgia, 30034
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Duarte, California, 91010
GSK Investigational Site
East Syracuse, New York, 13057
GSK Investigational Site
Edmonds, Washington, 98026
GSK Investigational Site
Elizabeth, New Jersey, 07202
GSK Investigational Site
Elkhart, Indiana, 46515
GSK Investigational Site
Elkridge, Maryland, 21075
GSK Investigational Site
Eugene, Oregon, 97404
GSK Investigational Site
Evansville, Indiana, 47714
GSK Investigational Site
Fenton, Missouri, 63026
GSK Investigational Site
Fort Meyers, Florida, 33907
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Gainsville, Florida, 32607
GSK Investigational Site
Galveston, Texas, 77555
GSK Investigational Site
Glendale, Arizona, 85306
GSK Investigational Site
Greensboro, North Carolina, 27401
GSK Investigational Site
Haddon Heights, New Jersey, 08035
GSK Investigational Site
Hollywood, Florida, 33021
GSK Investigational Site
Hot Springs, Arkansas, 71913
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Huntington Beach, California, 92648
GSK Investigational Site
Incline Village, Nevada, 89452
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Indianapolis, Indiana, 46250
GSK Investigational Site
Jacksonville, Florida, 32256
GSK Investigational Site
Jacksonville, Florida, 32257
GSK Investigational Site
Jupiter, Florida, 33458
GSK Investigational Site
Lacey, Washington, 98516
GSK Investigational Site
Lake Jackson, Texas, 77566
GSK Investigational Site
Largo, Florida, 33773
GSK Investigational Site
Las Vegas, Nevada, 89119
GSK Investigational Site
Las Vegas, Nevada, 89146
GSK Investigational Site
Lexington, Kentucky, 40504
GSK Investigational Site
Little Rock, Arkansas, 72223
GSK Investigational Site
Louisville, Kentucky, 40213
GSK Investigational Site
Manchester, Missouri, 63021
GSK Investigational Site
Marietta, Georgia, 30066
GSK Investigational Site
Maumee, Ohio, 43537
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Miami, Florida, 33145
GSK Investigational Site
Miami, Florida, 33186
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Murrells Inlet, South Carolina, 29576
GSK Investigational Site
Muscle Shoals, Alabama, 35662
GSK Investigational Site
Nazareth, Pennsylvania, 18064
GSK Investigational Site
New York, New York, 10010
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Newark, Delaware, 19713
GSK Investigational Site
Newburgh, Indiana, 47630
GSK Investigational Site
Niceville, Florida, 32578
GSK Investigational Site
North Miami, Florida, 33161
GSK Investigational Site
Ocala, Florida, 32607
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Omaha, Nebraska, 68114
GSK Investigational Site
Orange, California, 92869
GSK Investigational Site
Oregon City, Oregon, 97045
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Ormond Beach, Florida, 32174
GSK Investigational Site
Phoenix, Arizona, 85023
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Picayune, Mississippi, 39466
GSK Investigational Site
Portage, Michigan, 49024
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Portland, Oregon, 97225
GSK Investigational Site
Portland, Oregon, 97232
GSK Investigational Site
Princeton, New Jersey, 08540
GSK Investigational Site
Redlands, California, 92374
GSK Investigational Site
Rockford, Illinois, 61107
GSK Investigational Site
Saginaw, Michigan, 48602
GSK Investigational Site
Salisbury, North Carolina, 28144
GSK Investigational Site
San Antonio, Texas, 78205
GSK Investigational Site
San Antonio, Texas, 78238
GSK Investigational Site
San Diego, California, 92103-6204
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
San Diego, California, 92121
GSK Investigational Site
Sarasota, Florida, 34239
GSK Investigational Site
Shreveport, Louisiana, 71103
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
St Louis, Missouri, 63128
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
St. Petersburg, Florida, 33703
GSK Investigational Site
Sun City, Arizona, 85351
GSK Investigational Site
Tallassee, Alabama, 36078
GSK Investigational Site
Tampa, Florida, 33603
GSK Investigational Site
Tucson, Arizona, 85711
GSK Investigational Site
Tucson, Arizona, 85741
GSK Investigational Site
Valley Stream, New York, 11580
GSK Investigational Site
Virginia Beach, Virginia, 23452
GSK Investigational Site
Vista, California, 92083
GSK Investigational Site
Warwick, Rhode Island, 02886
GSK Investigational Site
Waterbury, Connecticut, 067708
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
Whitehall, Pennsylvania, 18052
GSK Investigational Site
Wilmington, North Carolina, 28412
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Winter Park, Florida, 32789
GSK Investigational Site
Woonsocket, Rhode Island, 02895
GSK Investigational Site
Wyomissing, Pennsylvania, 19610
Germany26 sites
GSK Investigational Site
Augsburg, Bavaria, 86150
GSK Investigational Site
Berlin, State of Berlin, 10115
GSK Investigational Site
Berlin, State of Berlin, 10117
GSK Investigational Site
Berlin, State of Berlin, 10409
GSK Investigational Site
Berlin, State of Berlin, 10435
GSK Investigational Site
Berlin, State of Berlin, 13125
GSK Investigational Site
Chemnitz, Saxony, 09111
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50924
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Fellbach, Baden-Wurttemberg, 70736
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20249
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22149
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22525
GSK Investigational Site
Hüttenberg, Hesse, 35625
GSK Investigational Site
Kiel, Schleswig-Holstein, 24105
GSK Investigational Site
Nuremberg, Bavaria, 90402
GSK Investigational Site
Pinneberg, Schleswig-Holstein, 25421
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
GSK Investigational Site
Viersen, North Rhine-Westphalia, 41749
GSK Investigational Site
Villingen-Schwenningen, Baden-Wurttemberg, 78054
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Wiesbaden, Hesse, 65195
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455
United Kingdom14 sites
GSK Investigational Site
Ashford, Middlesex, TW15 3EA
GSK Investigational Site
Bexhill-on-Sea, East Sussex, TN39 4SP
GSK Investigational Site
Blackpool, Lancashire, FY4 3AD
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, SE5 9RS
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
GSK Investigational Site
York, YO31 8HE
Canada12 sites
GSK Investigational Site
Brampton, Ontario, L6T 3J1
GSK Investigational Site
Chandler, Quebec, G0C 1K0
GSK Investigational Site
Edmonton, Alberta, T5A 4L8
GSK Investigational Site
Halifax, Nova Scotia, B3K 5R3
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
Montreal, Quebec, H3M 3A9
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1B 3E1
GSK Investigational Site
Toronto, Ontario, M9W 4L6
Denmark3 sites
GSK Investigational Site
Hvidovre, 2650
GSK Investigational Site
Ishøj, 2635
GSK Investigational Site
Odense C, 5000
Poland3 sites
GSK Investigational Site
Gdansk, 80-952
GSK Investigational Site
Krakow, 31-531
GSK Investigational Site
Wroclaw, 50-368
Austria2 sites
GSK Investigational Site
Vienna, A-1100
GSK Investigational Site
Vienna, A-1130
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 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.
- 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
Also called Entereg
0.5 mg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Alvimopan 0.5 mg once daily | Experimental | Not described Receives: Drug: alvimopan |
| alvimopan 0.5 mg twice daily | Experimental | Not described Receives: Drug: alvimopan |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare alvimopan with placebo for efficacy in the treatment of OBD
Secondary outcomes (1)
Safety and tolerability, quality of life, pharmacokinetics, 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.
- First posted22 Nov 2005 (estimated)
- Study startAug 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 518 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
- NCT00256932
- Sponsor's protocol ID
- SB-767905/012
- Status last verified
- Dec 2011
- First submitted
- 21 Nov 2005
- Last updated
- 2 Sep 2015
- Results posted
- No
Publications
Jansen JP, Lorch D, Langan J, Lasko B, Hermanns K, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/012) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):185-93. doi: 10.1016/j.jpain.2010.06.012.
PubMed 21292169
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 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
- ClinicalTrials.gov ID
- NCT00256932
- Acronym / sponsor ID
- SB-767905/012
- 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
- 518 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
- Aug 2005
- Study completion
- May 2006 (actual)
- First posted
- 22 Nov 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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Alvimopan 0.5 mg once daily | Experimental | Drug: alvimopan |
| alvimopan 0.5 mg twice daily | Experimental | Drug: alvimopan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has 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 |
|---|---|---|
| alvimopanAlso: Entereg0.5 mg | Drug | Alvimopan 0.5 mg once daily, alvimopan 0.5 mg twice daily |
| Placebo | Drug | Placebo |
Primary outcome
to compare alvimopan with placebo for efficacy in the treatment of OBD
1 secondary outcome
Safety and tolerability, quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)
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.
- Results publication: PubMed 21292169Jansen JP, Lorch D, Langan J, Lasko B, Hermanns K, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/012) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):185-93. doi: 10.1016/j.jpain.2010.06.012.
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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
200 sites in 10 countries: see every site and its status.
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 200 sites in 10 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 200 sites in United States, Germany, United Kingdom, Canada, Denmark and 5 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 NCT00256932, 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.