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Pulmonary FibrosisPhase 3STEP-IPFNCT00517933

Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis

A Phase 3 study testing Sildenafil Citrate in people with Pulmonary Fibrosis and Hypertension, Pulmonary, run by Duke University at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication that increases blood flow to the lungs, at improving breathing function, exercise capacity, and quality of life in people with advanced… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Fibrosis, Hypertension, Pulmonary
What is being tested?
Sildenafil Citrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
13 sitesUnited States
Study dates
Aug 2007to Oct 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Clinical diagnosis of IPF
  • Diffusing capacity of the lung (DLCO) level less than 35% (adjusted for hemoglobin)

Who cannot join

  • Current enrollment in another investigational study
  • Six-minute walk distance of less than 50 meters at screening or study entry
  • Difference of greater than 15% between the screening and study entry 6-minute walk distance
  • Acute or long-term impairment other than dyspnea (e.g., angina pectoris, intermittent claudication) that limits the ability to comply with the 6-minute walk test or other study requirements
  • Forced Expiratory Volume 1-second (FEV1)/forced vital capacity (FVC) ratio of less than 0.65 after bronchodilator use
  • Extent of emphysema greater than the extent of fibrotic change (e.g., honeycombing, reticular changes) on high-resolution computed tomography (HRCT) scan
Show all 35Show fewer
  • Acute heart attack within the 6 months prior to study entry
  • Nitrate use
  • Hypersensitivity to sildenafil or any component of the formulation
  • Presence of aortic stenosis (AS)
  • Life-threatening arrhythmia within 1 month of study entry
  • Diabetes mellitus requiring insulin therapy
  • Second-degree or third-degree atrioventricular (AV) block on electrocardiogram
  • Severe chronic heart failure, defined by left ventricular ejection fraction (LVEF) of less than 25%
  • Presence of idiopathic hypertrophic subaortic stenosis (IHSS)
  • Hypotension (i.e., systolic blood pressure [SBP] less than 100 mm Hg or diastolic blood pressure [DBP] less than 50 mm Hg)
  • Uncontrolled systemic hypertension (i.e., SBP greater than 180 mm Hg or DBP greater than 100 mm Hg)
  • Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose participant to priapism
  • Aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT), alanine aminotransferase (ALT), or serum glutamic oxaloacetic transaminase (SGOT) greater than three times the upper limit of normal range
  • Kidney impairment (i.e., creatinine clearance less than 30 mL/minute)
  • Current drug or alcohol dependence
  • Retinitis pigmentosa
  • History of vision loss
  • History of nonarteritic ischemic optic neuropathy
  • Recently initiated pulmonary rehabilitation within 30 days of study entry. Participants will be prohibited from starting pulmonary rehabilitation during the study. Participants who are currently undergoing maintenance pulmonary rehabilitation at study entry will be asked to maintain their levels of rehabilitation for the duration of the study.
  • Use of any investigational therapy as part of a clinical trial for any medical condition within 30 days of study entry
  • Start or change in dose of treatment for IPF investigational agent (e.g., interferon gamma-1b, pirfenidone, etanercept, N-acetylcysteine, any other investigational agent intended to treat IPF), corticosteroids, or cytotoxic agents within 30 days of study entry
  • Use of certain medications. More information about this criterion can be found in the study protocol.
  • Treatment for pulmonary hypertension with prostaglandins (e.g., epoprostenol, treprostinil), endothelin-1 antagonists (e.g., bosentan, sitaxsentan, ambrisentan), or any other phosphodiesterase inhibitor (e.g., tadalafil, vardenafil) within 30 days of study entry
  • Addition or discontinuation of calcium channel blockers, digitalis, diuretics, or vasodilators within 30 days of study entry (dosage must be stable for 7 days prior to study entry [except for diuretics])
  • Currently on the waiting list for a lung transplant
  • Use of L-arginine supplements
  • Use of grapefruit juice or St. John's wort
  • Pregnant or breastfeeding
  • Resting saturation of peripheral oxygen (SpO2) (i.e., oxygen saturation measured using pulse oximetry) less than 92% with 6 liters of supplemental oxygen

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • University of Chicago

    Chicago, Illinois, 60637

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of California - Los Angeles

    Los Angeles, California, 90095

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Tulane University

    New Orleans, Louisiana, 70118

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California - San Francisco

    San Francisco, California, 94110

  • University of Washington

    Seattle, Washington, 98165

Other trials in United States

About this study

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication that increases blood flow to the lungs, at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.

Read the detailed description

IPF is a disease in which fibrous tissue clogs the lungs. This eventually damages air sacs in the lungs and leads to widespread and permanent scarring of lung tissue. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased exercise capacity. Pulmonary hypertension, which is high blood pressure in the arteries of the lungs, affects half of all people with IPF. The fibrous tissue that clogs the lungs also blocks blood from flowing through the lungs effectively, reducing the amount of oxygen in the lungs. The fibrous tissue also reduces the lungs' ability to use what oxygen is available. These factors can cause breathing difficulties and may eventually lead to heart disease. Sildenafil is a medication that can increase blood supply to the lungs and reduce the heart's workload. The purpose of this study is to evaluate the effectiveness of sildenafil at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.

This study will enroll people with advanced IPF. Participants will be randomly assigned to receive sildenafil or placebo three times a day for 12 weeks. Study visits will occur at baseline and Weeks 1, 6, and 12. At Week 12, participants will have the option to continue in the study for an additional 12 weeks. All participants who agree to continue in the study will receive sildenafil three times a day for the second 12 weeks. Study visits will occur at Weeks 13, 18, and 24. At all study visits, a physical exam and blood collection will occur. At selected visits, the following study procedures will occur: lung function testing; urine collection; a 6-minute walk test, which will measure the distance walked in a 6-minute period; and questionnaires to assess health status, breathing, and quality of life. Participants will record medication usage and symptoms in a daily diary. Study researchers will review medical records and the Social Security death index 5 years following the end of the study to determine the incidence of death among study participants.

Being tested
Sildenafil Citrate, Placebo
Keywords
Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension
Medical subject headings
Pulmonary Fibrosis, Hypertension, Pulmonary, Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sildenafil CitrateDrug

    Also called Revatio

    Sildenafil citrate (20mg 3 times a day [TID] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks)

  • PlaceboOther

    Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks)

Study groups in NCT00517933
Study groupRoleWhat they receive
SildenafilActive comparator20 mg of sildenafil 3 times a day (TID) for 12 weeks followed by 20 mg of sildenafil TID for an additional 12 weeks
Receives: Drug: Sildenafil Citrate
Placebo / SildanafilPlacebo comparator20 mg of placebo TID for 12 weeks followed by 20 mg of sildenafil citrate TID for an additional 12 weeks
Receives: Other: Placebo

What is being measured

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

  1. Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)

    This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Measured at Week 12

Secondary outcomes (29)

  1. 6-minute Walk Distance (6MWT)

    The 6MWT measures the distance that a participant can walk in a period of 6 minutes.

    Measured: Baseline, 6 week, 12 week

  2. Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance

    The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, week 12

  3. Desaturation During 6-minute Walk Test (6MWT)

    The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.

    Measured: Week 12

  4. Change in Dyspnea

    The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better.

    Measured: Measured from enrollment to 12 weeks (phase I)

  5. University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total

    The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores)

    Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 6 weeks, 12 weeks

  6. Change in Forced Vital Capacity (FVC) Adjusted Values

    Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, Week 12

  7. Forced Vital Capacity (FVC)

    Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups

    Measured: Baseline, Week 6, Week 12

  8. Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values

    Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, Week 12

  9. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

    Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups

    Measured: Baseline, Week 6, Week 12

  10. Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)

    The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 week

  11. Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)

    The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test.

    Measured: Baseline, 6 week, 12 week

  12. Change in St. George's Respiratory Questionnaire (Total Score) (Adjusted Values)

    The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 week

  13. St. George's Respiratory Questionnaire (Total Score)

    Mean raw scores of the St. George's Respiratory Questionnaire. The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.)

    Measured: Baseline, 6 weeks, 12 weeks

  14. Change in St. George's Respiratory Questionnaire (Symptoms Score) Adjusted Value

    The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 weeks

  15. St. George's Respiratory Questionnaire (Symptoms Score)

    The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George's Respiratory Questionnaire.

    Measured: Baseline, 6 weeks, 12 weeks

  16. Change in St. George's Respiratory Questionnaire (Activity Score) Adjusted Value

    The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 weeks

  17. St. George's Respiratory Questionnaire (Activity Score)

    The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.

    Measured: Baseline, 6 weeks, 12 weeks

  18. Change in St. George's Respiratory Questionnaire (Impacts Score) Adjusted Value

    The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 weeks

  19. St. George's Respiratory Questionnaire (Impacts Score)

    The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.

    Measured: Baseline, 6 weeks, 12 weeks

  20. Change in ICECAP-O Adjusted Value

    The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best).

    Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 weeks

  21. ICECAP-O

    The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O.

    Measured: Baseline, 6 weeks, 12 weeks

  22. Change in EuroQOL Thermometer (Adjusted Value)

    The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.

    Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 weeks

  23. EuroQOL Thermometer

    The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.

    Mean raw scores of EuroQOL Thermometer.

    Measured: Baseline, 6 weeks, 12 weeks

  24. Change in EuroQOL (EQ-5D) Utility - Adjusted Value

    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.

    Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 weeks

  25. EuroQOL (EQ-5D) Utility

    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.

    Mean raw scores of EuroQOL Utility.

    Measured: Baseline, 6 weeks, 12 weeks

  26. Change in Short Form Health Survey (SF36) General Health - Adjusted Value

    The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.

    Each score ranges from 0 to 100, with a higher score indicating better function.

    Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 weeks

  27. Short Form Health Survey (SF36) General Health

    The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.

    Each score ranges from 0 to 100, with a higher score indicating better function.

    Mean raw scores of SF36 General Health

    Measured: Baseline, 6 weeks, 12 weeks

  28. Change in SF36 Aggregate Physical (Adjusted Value)

    The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.

    Each score ranges from 0 to 100, with a higher score indicating better function.

    Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured: Baseline, 12 weeks

  29. Short Form Health Survey (SF36) Aggregate Physical

    The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.

    Each score ranges from 0 to 100, with a higher score indicating better function.

    Mean raw scores of SF36 Aggregate Physical.

    Measured: Baseline, 6 weeks, 12 weeks

Timeline

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

  1. First posted17 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionMay 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00517933
Sponsor's protocol ID
Pro00018538
Other IDs
U10HL080413, 507
Acronym
STEP-IPF
Status last verified
Jun 2015
First submitted
15 Aug 2007
Last updated
24 Jun 2015
Data monitoring committee
Yes

Publications

  • Andrade J, Schwarz M, Collard HR, Gentry-Bumpass T, Colby T, Lynch D, Kaner RJ; IPFnet Investigators. The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet): diagnostic and adjudication processes. Chest. 2015 Oct;148(4):1034-1042. doi: 10.1378/chest.14-2889.

    PubMed 26111071

  • Durheim MT, Collard HR, Roberts RS, Brown KK, Flaherty KR, King TE Jr, Palmer SM, Raghu G, Snyder LD, Anstrom KJ, Martinez FJ; IPFnet investigators. Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials. Lancet Respir Med. 2015 May;3(5):388-96. doi: 10.1016/S2213-2600(15)00093-4. Epub 2015 Apr 15.

    PubMed 25890798

  • Idiopathic Pulmonary Fibrosis Clinical Research Network; Zisman DA, Schwarz M, Anstrom KJ, Collard HR, Flaherty KR, Hunninghake GW. A controlled trial of sildenafil in advanced idiopathic pulmonary fibrosis. N Engl J Med. 2010 Aug 12;363(7):620-8. doi: 10.1056/NEJMoa1002110. Epub 2010 May 18.

    PubMed 20484178

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sildenafil Citrate in people with Pulmonary Fibrosis and Hypertension, Pulmonary, run by Duke University at 13 sites 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 2 inclusion and 35 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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. 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?

Yes. Results are posted in the registry (first posted 23 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement) (time frame: Measured at Week 12). 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 NCT00517933, which also lists 3 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 24 Jun 2015.

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