OsteoarthritisPhase 2NCT01463189
Web-based Support to Manage Arthritis Pain
A Phase 2 study testing painACTION: Arthritis in people with Osteoarthritis and Rheumatoid Arthritis, run by Inflexxion, Inc. at 1 site in United States.
Trial summary
Development of an interactive, online pain self-management program for adults who suffer from pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive Theory (Bandura, 1977). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- What is being tested?
- painACTION: Arthritis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age;
- Be able to provide informed consent
- Be able to read and speak English
- Have reliable Internet access and e-mail
- Have a self-reported doctor diagnosis of arthritis, limited to the following conditions - osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), or other arthritis conditions (e.g., psoriatic arthritis)
- Have a self-reported pain level of 4 or more in the past week on the 0 to 10 Numeric Rating Scale (McCaffery \& Beebe, 1993) because 4 indicates moderate or higher level of pain.
Who cannot join
- Participation in another Inflexxion pain management study.
- Participation in an online research study related to arthritis in the past year
- Currently in pain from a recent injury
- Has been hospitalized for non-medical reasons related to emotional or mental health in the past year
Trial locations and contacts
1 site in 1 country.
About this study
Development of an interactive, online pain self-management program for adults who suffer from pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive Theory (Bandura, 1977). This online health intervention, painACTION: Arthritis, will provide clinically reliable information about diagnosis, treatment, and management of arthritis, written for health consumers in a clear and engaging manner to help increase their skills and confidence to use self-management strategies.
Read the detailed description
One of every five adults in the United States (46.4 million people) is affected by arthritis. Increasing the number of days individuals are free of arthritis pain is one of the Healthy People 2010 objectives. Although there are a variety of medical treatments and medications available, self-management is a critical component in helping arthritis sufferers learn how to identify, avoid, and help manage their pain. Unfortunately, clinicians face significant time pressure, leaving little time for desired patient-provider education and collaboration. This is an important omission as tailored advice (e.g., specific exercises to reduce pain) from health providers could enable behavior change and improve outcomes. Therefore, widely accessible and tailored interventions that address motivational issues are needed to facilitate self-management education among arthritis patients. Because of its reach across demographic groups, the Internet is an excellent vehicle for offering a self-management program to arthritis sufferers. The investigators propose to develop an interactive, online pain self-management program for adults who suffer from pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive Theory (Bandura, 1977). This online health intervention, painACTION: Arthritis, will provide clinically reliable information about diagnosis, treatment, and management of arthritis, written for health consumers in a clear and engaging manner to help increase their skills and confidence to use self-management strategies. Moreover, it will be designed to complement and connect to our other SBIR-supported pain online health interventions (chronic back pain, migraine pain, neuropathic pain) to be a more comprehensive resource for those seeking pain management assistance. The most unique aspect of painACTION: Arthritis is that it includes three technological innovations -- a Web 2.0-enabled platform, a Custom Recommendation Engine, and Dynamic Lessons - to help people self manage their arthritis pain. In Phase I the investigators accomplished two important objectives: 1) established the feasibility of painACTION: Arthritis as an intervention and a technical project and 2) generated preliminary plans for the content, design, and technical development of painACTION: Arthritis. In Phase II the investigators will produce the program and test its efficacy.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Other Arthritic Conditions (e.g., Psoriatic Arthritis)
- Being tested
- painACTION: Arthritis
- Keywords
- arthritis, self management
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painACTION: ArthritisBehavioural
Participants will be asked to complete eight 20-minute sessions on the site over a four-week intervention period (two site visits per week), and complete five 20-minute "booster" sessions (one site visit per month) during the follow up period. Each session will have a minimum set of requirements. Specific details about the requirements for each session will be provided in the session logs.
| Study group | Role | What they receive |
|---|---|---|
| painACTION: Arthritis | Experimental | Not described Receives: Behavioral: painACTION: Arthritis |
| treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitions from baseline to: post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Arthritis Self-efficacy Scale (Lorig et al., 1989) is an 8-item questionnaire that assesses a patient's ability to determine self-efficacy.
Pain Catastrophizing Scale (PCS) (Sullivan et al., 1995) was developed to assess three components of catastrophizing: rumination, magnification, and helplessness. The scale consists of 13 items rated from 0-4 (0 = not at all, 4 = all the time).
Pain Awareness Questionnaire (Berman et al., 2009) is a 7-item questionnaire that assesses a patient's awareness of their current pain.
Measured: baseline, post intervention, 3 months post intervention, and 6 months post intervention
Change in self management behaviors from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Exercise Behaviors (Lorig et al., 1996) is a 6-item questionnaire assessing the total time a patient had participated in various forms of exercise (e.g., stretching).
Cognitive Symptom Management (Lorig et al., 1996) is a 6-item questionnaire assessing a patient's ability to manage their symptoms. This scale is rated on a 0 to 5 scale: 0 = never to 5 = always.
Communication with Physicians (Lorig et al., 1996) is a 3-item scale assessing a patient's communication with their physicians. This scale is rated on a 0 to 5 scale: 0 = never to 5 = always.
Measured: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
Change in pain and functioning from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Brief Pain Inventory - Short Form (BPI-SF) (Cleeland, 1991) uses a 0 to 10 numeric rating scale to obtain information on the intensity of pain, the degree to which pain interferes with function, pain relief, pain quality, and the patient's perception of the cause of pain (6 items).
Measured: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
Secondary outcomes (2)
Change in quality of life from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
The Arthritis Impact Measurement Scale-2-SF (Guillemin et al., 1997) is a 26-item scale that measures 5-domains of health status (e.g., physical, role, work, and social functioning.) Six additional items from the Ankylosing Spondylitis-AIMS will be added for additional validity of spine and mobility functioning for the participants with AS (Guillemin et al., 1999).
Patient Global Impression of Change Scale (Guy, 1976) is an outcome measure of global improvement with treatment and consists of a single-item self-rating.
Measured: baseline, post intervention, 3 months post intervention, and 6 months post intervention
Change in affect from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Depression Anxiety Stress Scales (DASS-21, Lovibond \& Lovibond, 1995). The DASS is a 21-item questionnaire that distinguishes symptoms of depression, anxiety, and stress.
Measured: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflexxion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Kimberlee Trudeau, Inflexxion, Inc.
- Investigators
- Kimberlee J Trudeau, Ph.D., Principal investigator, Inflexxion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463189
- Sponsor's protocol ID
- 5R44AR061191
- Status last verified
- Dec 2012
- First submitted
- 20 Oct 2011
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
PubMed 847061Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.
PubMed 2912463Lorig K, Stewart A, Ritter P, González V, Laurent D, Lynch J. Outcome measures for health education and other health care interventions. Thousand Oaks, CA: Sage Publications, 1996.
Sullivan MJL. The pain catastrophizing scale: Development and validation. Psychological Assessment 7(4):524-532, 1995.
Berman RL, Iris MA, Bode R, Drengenberg C. The effectiveness of an online mind-body intervention for older adults with chronic pain. J Pain. 2009 Jan;10(1):68-79. doi: 10.1016/j.jpain.2008.07.006. Epub 2008 Sep 5.
PubMed 18774342Cleeland CS. Brief Pain Inventory (Short Form). Pain Research Group. Retrieved March 17, 2009, from http://prc.coh.org/pdf/BPI%20Short%20Version.pdf, 1991.
Guillemin F, Coste J, Pouchot J, Ghezail M, Bregeon C, Sany J. The AIMS2-SF: a short form of the Arthritis Impact Measurement Scales 2. French Quality of Life in Rheumatology Group. Arthritis Rheum. 1997 Jul;40(7):1267-74. doi: 10.1002/1529-0131(199707)40:73.0.CO;2-L.
PubMed 9214427Guillemin F, Challier B, Urlacher F, Vancon G, Pourel J. Quality of life in ankylosing spondylitis: validation of the ankylosing spondylitis Arthritis Impact Measurement Scales 2, a modified Arthritis Impact Measurement Scales Questionnaire. Arthritis Care Res. 1999 Jun;12(3):157-62. doi: 10.1002/1529-0131(199906)12:33.0.co;2-r.
PubMed 10513505Guy W. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare, 1976.
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811McCaffery M, Beebe A. Pain: Clinical Manual for Nursing Practice. Baltimore: V.V. Mosby Company, 1993.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Support to Manage Arthritis Pain
- ClinicalTrials.gov ID
- NCT01463189
- Acronym / sponsor ID
- 5R44AR061191
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Other Arthritic Conditions (e.g., Psoriatic Arthritis)
- Keywords
- arthritis, self management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Inflexxion, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Nov 2011 (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.
Development of an interactive, online pain self-management program for adults who suffer from pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive Theory (Bandura, 1977). This online health intervention, painACTION: Arthritis, will provide clinically reliable information about diagnosis, treatment, and management of arthritis, written for health consumers in a clear and engaging manner to help increase their skills and confidence to use self-management strategies.
Detailed description
One of every five adults in the United States (46.4 million people) is affected by arthritis. Increasing the number of days individuals are free of arthritis pain is one of the Healthy People 2010 objectives. Although there are a variety of medical treatments and medications available, self-management is a critical component in helping arthritis sufferers learn how to identify, avoid, and help manage their pain. Unfortunately, clinicians face significant time pressure, leaving little time for desired patient-provider education and collaboration. This is an important omission as tailored advice (e.g., specific exercises to reduce pain) from health providers could enable behavior change and improve outcomes. Therefore, widely accessible and tailored interventions that address motivational issues are needed to facilitate self-management education among arthritis patients. Because of its reach across demographic groups, the Internet is an excellent vehicle for offering a self-management program to arthritis sufferers. The investigators propose to develop an interactive, online pain self-management program for adults who suffer from pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive Theory (Bandura, 1977). This online health intervention, painACTION: Arthritis, will provide clinically reliable information about diagnosis, treatment, and management of arthritis, written for health consumers in a clear and engaging manner to help increase their skills and confidence to use self-management strategies. Moreover, it will be designed to complement and connect to our other SBIR-supported pain online health interventions (chronic back pain, migraine pain, neuropathic pain) to be a more comprehensive resource for those seeking pain management assistance. The most unique aspect of painACTION: Arthritis is that it includes three technological innovations -- a Web 2.0-enabled platform, a Custom Recommendation Engine, and Dynamic Lessons - to help people self manage their arthritis pain. In Phase I the investigators accomplished two important objectives: 1) established the feasibility of painACTION: Arthritis as an intervention and a technical project and 2) generated preliminary plans for the content, design, and technical development of painACTION: Arthritis. In Phase II the investigators will produce the program and test its efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| painACTION: Arthritis | Experimental | Behavioral: painACTION: Arthritis |
| treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years of age;
- Be able to provide informed consent
- Be able to read and speak English
- Have reliable Internet access and e-mail
- Have a self-reported doctor diagnosis of arthritis, limited to the following conditions - osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), or other arthritis conditions (e.g., psoriatic arthritis)
Key exclusion criteria (4 listed)
- Participation in another Inflexxion pain management study.
- Participation in an online research study related to arthritis in the past year
- Currently in pain from a recent injury
- Has been hospitalized for non-medical reasons related to emotional or mental health in the past year
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 |
|---|---|---|
| painACTION: ArthritisParticipants will be asked to complete eight 20-minute sessions on the site over a four-week intervention period (two site visits per week), and complete five 20-minute "booster" sessions (one site visit per month) during the follow up period. Each session will have a minimum set of requirements. Specific details about the requirements for each session will be provided in the session logs. | Behavioural | painACTION: Arthritis |
Primary outcome
Change in cognitions from baseline to: post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Time frame: baseline, post intervention, 3 months post intervention, and 6 months post intervention
Arthritis Self-efficacy Scale (Lorig et al., 1989) is an 8-item questionnaire that assesses a patient's ability to determine self-efficacy. Pain Catastrophizing Scale (PCS) (Sullivan et al., 1995) was developed to assess three components of catastrophizing: rumination, magnification, and helplessness. The scale consists of 13 items rated from 0-4 (0 = not at all, 4 = all the time). Pain Awareness Questionnaire (Berman et al., 2009) is a 7-item questionnaire that assesses a patient's awareness of their current pain.
Change in self management behaviors from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Time frame: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
Exercise Behaviors (Lorig et al., 1996) is a 6-item questionnaire assessing the total time a patient had participated in various forms of exercise (e.g., stretching). Cognitive Symptom Management (Lorig et al., 1996) is a 6-item questionnaire assessing a patient's ability to manage their symptoms. This scale is rated on a 0 to 5 scale: 0 = never to 5 = always. Communication with Physicians (Lorig et al., 1996) is a 3-item scale assessing a patient's communication with their physicians. This scale is rated on a 0 to 5 scale: 0 = never to 5 = always.
Change in pain and functioning from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Time frame: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
Brief Pain Inventory - Short Form (BPI-SF) (Cleeland, 1991) uses a 0 to 10 numeric rating scale to obtain information on the intensity of pain, the degree to which pain interferes with function, pain relief, pain quality, and the patient's perception of the cause of pain (6 items).
2 secondary outcomes
Change in quality of life from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Time frame: baseline, post intervention, 3 months post intervention, and 6 months post intervention
Change in affect from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Time frame: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
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 10 Dec 2012.
- Background: PubMed 847061Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
- Background: PubMed 2912463Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.
- BackgroundLorig K, Stewart A, Ritter P, González V, Laurent D, Lynch J. Outcome measures for health education and other health care interventions. Thousand Oaks, CA: Sage Publications, 1996.
- BackgroundSullivan MJL. The pain catastrophizing scale: Development and validation. Psychological Assessment 7(4):524-532, 1995.
- Background: PubMed 18774342Berman RL, Iris MA, Bode R, Drengenberg C. The effectiveness of an online mind-body intervention for older adults with chronic pain. J Pain. 2009 Jan;10(1):68-79. doi: 10.1016/j.jpain.2008.07.006. Epub 2008 Sep 5.
- BackgroundCleeland CS. Brief Pain Inventory (Short Form). Pain Research Group. Retrieved March 17, 2009, from http://prc.coh.org/pdf/BPI%20Short%20Version.pdf, 1991.
- Background: PubMed 9214427Guillemin F, Coste J, Pouchot J, Ghezail M, Bregeon C, Sany J. The AIMS2-SF: a short form of the Arthritis Impact Measurement Scales 2. French Quality of Life in Rheumatology Group. Arthritis Rheum. 1997 Jul;40(7):1267-74. doi: 10.1002/1529-0131(199707)40:73.0.CO;2-L.
- Background: PubMed 10513505Guillemin F, Challier B, Urlacher F, Vancon G, Pourel J. Quality of life in ankylosing spondylitis: validation of the ankylosing spondylitis Arthritis Impact Measurement Scales 2, a modified Arthritis Impact Measurement Scales Questionnaire. Arthritis Care Res. 1999 Jun;12(3):157-62. doi: 10.1002/1529-0131(199906)12:33.0.co;2-r.
- BackgroundGuy W. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare, 1976.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- BackgroundMcCaffery M, Beebe A. Pain: Clinical Manual for Nursing Practice. Baltimore: V.V. Mosby Company, 1993.
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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.
Kimberlee J Trudeau, Ph.D. principal investigator
Inflexxion, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing painACTION: Arthritis in people with Osteoarthritis and Rheumatoid Arthritis, run by Inflexxion, Inc. at 1 site in United States.
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 4 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 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 cognitions from baseline to: post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention (time frame: baseline, post intervention, 3 months post intervention, and 6 months post intervention). The study lists 3 primary outcomes in all. 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 NCT01463189, which also lists 11 linked publications.
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 10 Dec 2012.