Pulmonary Disease, Chronic ObstructivePhase 3NCT01040130

Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I

A Phase 3 study testing Olodaterol (BI 1744) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 19 sites in 5 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

To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Olodaterol (BI 1744)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 151 participants
Where: 19 sitesin 5 countries
Study dates: Jan 2010to Apr 2011
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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent prior to participation.
Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1.
Male or female between 40 and 75 years of age.
Current or ex-smokers with smoking history of more than 10-pack years.
Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records.
Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler.

Who cannot join

Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN.
Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.
Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute).
Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise.
Patients who have undergone thoracotomy with pulmonary resection.
Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.

Show all 11Show fewer

Patients who regularly use daytime oxygen for more than one hour per day.
Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea.
Pregnant or nursing women.
Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).

Trial locations and contacts

19 sites in 5 countries.

Country

City, postcode or hospital

19 sites in 5 countries

France6 sites

1222.37.33005 Boehringer Ingelheim Investigational Site
Béthune
1222.37.33002 Boehringer Ingelheim Investigational Site
Montpellier
1222.37.33001 Boehringer Ingelheim Investigational Site
Nîmes
1222.37.33006 Boehringer Ingelheim Investigational Site
Paris
1222.37.33004 Boehringer Ingelheim Investigational Site
Perpignan
1222.37.33003 Boehringer Ingelheim Investigational Site
Strasbourg

Other trials in France

Australia4 sites

1222.37.6174 Boehringer Ingelheim Investigational Site
Clayton, Victoria
1222.37.6171 Boehringer Ingelheim Investigational Site
Daw Park, South Australia
1222.37.6173 Boehringer Ingelheim Investigational Site
Heidelberg, Victoria
1222.37.6172 Boehringer Ingelheim Investigational Site
Melbourne, Victoria

Other trials in Australia

Germany4 sites

1222.37.4970 Boehringer Ingelheim Investigational Site
Berlin
1222.37.4972 Boehringer Ingelheim Investigational Site
Halle
1222.37.4973 Boehringer Ingelheim Investigational Site
Magdeburg
1222.37.4971 Boehringer Ingelheim Investigational Site
Rüdersdorf

Other trials in Germany

Canada3 sites

1222.37.1072 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1222.37.1074 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1222.37.1073 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec

Other trials in Canada

Austria2 sites

1222.37.4371 Boehringer Ingelheim Investigational Site
Gänserndorf
1222.37.4372 Boehringer Ingelheim Investigational Site
Neumarkt am Wallersee

Other trials in Austria

About this study

Official title: Randomised, Double-blind, Placebo-controlled, 3-way Cross-over Study to Determine the Effect of Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 µg] and 10 µg [2 Actuations of 5 µg]) Delivered by the Respimat® Inhaler on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease

To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Olodaterol (BI 1744), Placebo, Olodaterol (BI 1744) Placebo
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

Olodaterol (BI 1744)Drug
Comparison of low and high doses on exercise endurance time in COPD patients
Olodaterol (BI 1744)Drug
Comparison of low and high doses on exercise endurance time in COPD patients
PlaceboDrug
Comparison of low and high dose and placebo on exercise endurance time in COPD patients
Olodaterol (BI 1744)Drug
Comparison of low and high dose
Olodaterol (BI 1744) PlaceboDrug
Placebo that represents olodaterol

Study groups in NCT01040130
Study group	Role	What they receive
Olodaterol (BI 1744) Low	Experimental	Low dose inhaled orally once daily from the Respimat inhaler Receives: Drug: Olodaterol (BI 1744); Drug: Olodaterol (BI 1744) Placebo
Olodaterol (BI 1744) High	Experimental	High dose inhaled orally once daily from the Respimat inhaler Receives: Drug: Olodaterol (BI 1744)
Placebo	Placebo comparator	Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler Receives: Drug: Placebo

What is being measured

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

Adjusted Mean Endurance Time After 6 Weeks
Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.
Measured: 6 weeks

Secondary outcomes (23)

Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks
Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.
Measured: 6 weeks
Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks
Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.
Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
Measured: 6 weeks
Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
Measured: 6 weeks
Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks
Measured: 6 weeks
Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks
Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
Measured: 6 weeks
Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks
Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
Measured: 6 weeks
Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks
Measured: 6 weeks
Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks
Measured: 6 weeks
Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks
Measured using body plethysmography
Measured: 6 weeks
Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks
Measured using body plethysmography
Measured: 6 weeks
Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks
Measured using body plethysmography
Measured: 6 weeks
Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks
Measured: 6 weeks
Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks
Measured: 6 weeks
Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks
Measured: 6 weeks
Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks
Measured: 6 weeks
Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks
Measured: 6 weeks
Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks
Measured: 6 weeks
Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks
Measured: 6 weeks
Change From Baseline to Day 43 in Blood Pressure
Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.
Measured: Baseline and Week 6
Change From Baseline to Day 43 in Pulse Rate
Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.
Measured: Baseline and Week 6
Number of Patients With Notable Changes in Heart Rate
Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.
Measured: Baseline and Week 6
Number of Patients With Notable Increase in PR Intervals
Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.
Measured: Baseline and Week 6
Number of Patients With Notable Increase in QRS Intervals
Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.
Measured: Baseline and Week 6

Timeline

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

Jan 2010Apr 2011

First posted29 Dec 2009 (estimated)
Study startJan 2010
Primary completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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: Crossover
Masking: Double blind
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01040130
Sponsor's protocol ID: 1222.37
Other IDs: 2009-014395-21, 2009
Status last verified: Jul 2014
First submitted: 28 Dec 2009
Last updated: 8 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Maltais F, Kirsten AM, Hamilton A, De Sousa D, Voss F, Decramer M. Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies. Respir Res. 2016 Jul 6;17(1):77. doi: 10.1186/s12931-016-0389-5.
PubMed 27383762

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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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Double-blind, Placebo-controlled, 3-way Cross-over Study to Determine the Effect of Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 µg] and 10 µg [2 Actuations of 5 µg]) Delivered by the Respimat® Inhaler on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT01040130
Acronym / sponsor ID: 1222.37
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Apr 2011 (actual)
First posted: 29 Dec 2009 (estimated)
Results: Posted 8 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
Olodaterol (BI 1744) Low	Experimental	Drug: Olodaterol (BI 1744), Drug: Olodaterol (BI 1744) PlaceboLow dose inhaled orally once daily from the Respimat inhaler
Olodaterol (BI 1744) High	Experimental	Drug: Olodaterol (BI 1744)High dose inhaled orally once daily from the Respimat inhaler
Placebo	Placebo comparator	Drug: PlaceboOlodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Signed informed consent prior to participation.
Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1.
Male or female between 40 and 75 years of age.
Current or ex-smokers with smoking history of more than 10-pack years.
Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records.

Key exclusion criteria (11 listed)

Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN.
Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.
Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute).
Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise.
Patients who have undergone thoracotomy with pulmonary resection.

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
Olodaterol (BI 1744)Comparison of low and high doses on exercise endurance time in COPD patients	Drug	Olodaterol (BI 1744) High
Olodaterol (BI 1744)Comparison of low and high doses on exercise endurance time in COPD patients	Drug	Olodaterol (BI 1744) Low
PlaceboComparison of low and high dose and placebo on exercise endurance time in COPD patients	Drug	Placebo
Olodaterol (BI 1744)Comparison of low and high dose	Drug	Olodaterol (BI 1744) Low
Olodaterol (BI 1744) PlaceboPlacebo that represents olodaterol	Drug	Olodaterol (BI 1744) Low

Primary outcome

Adjusted Mean Endurance Time After 6 Weeks
Time frame: 6 weeks
Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.

23 secondary outcomes

Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks
Time frame: 6 weeks
Change From Baseline to Day 43 in Blood Pressure
Time frame: Baseline and Week 6
Change From Baseline to Day 43 in Pulse Rate
Time frame: Baseline and Week 6
Number of Patients With Notable Changes in Heart Rate
Time frame: Baseline and Week 6
Number of Patients With Notable Increase in PR Intervals
Time frame: Baseline and Week 6
Number of Patients With Notable Increase in QRS Intervals
Time frame: Baseline and Week 6

Results and safety

Results posted to the registry on 8 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo / Olo 5mcg / Olo 10mcg	25	22
Placebo / Olo 10mcg / Olo 5mcg	25	22
Olo 5mcg / Placebo / Olo 10mcg	25	23
Olo 5mcg / Olo 10mcg / Placebo	25	20
Olo 10mcg / Placebo / Olo 5mcg	25	25
Olo 10mcg / Olo 5mcg / Placebo	26	22

Primary outcome: Adjusted Mean Endurance Time After 6 Weeks

Time frame: 6 weeks. Geometric mean (Standard Error). Unit: seconds

Measure	Placebo n = 136	Olo 5 mcg qd n = 140	Olo 10 mcg qd n = 136
Value	369.81 (11.941)	421.58 (13.459)	420.72 (13.602)

Placebo vs Olo 5 mcg qd: Ratio to placebo: 1.140 (95% CI 1.065 to 1.221), p = 0.0002, Mixed Models Analysis
Placebo vs Olo 10 mcg qd: Ratio to placebo: 1.138 (95% CI 1.062 to 1.219), p = 0.0003, Mixed Models Analysis

Population analysed: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 143 (2.1%)	8 of 143 (5.6%)	Not reported
Olo 5 mcg	3 of 147 (2%)	10 of 147 (6.8%)	Not reported
Olo 10 mcg	3 of 143 (2.1%)	5 of 143 (3.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27383762Maltais F, Kirsten AM, Hamilton A, De Sousa D, Voss F, Decramer M. Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies. Respir Res. 2016 Jul 6;17(1):77. doi: 10.1186/s12931-016-0389-5.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

19 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olodaterol (BI 1744) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 19 sites in 5 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 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, Australia, Germany, Canada, Austria. 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 8 Jul 2014). 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?

Adjusted Mean Endurance Time After 6 Weeks (time frame: 6 weeks). 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 NCT01040130, 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 8 Jul 2014.