AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 4NCT01762800

Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg

A Phase 4 study testing fluticasone propionate/salmeterol 50/250mcg, tiotropium bromide 18mcg and fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 39 sites in Japan.

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

The purpose of this study is to assess the control of COPD using a symptom and exacerbation risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese subjects with COPD and assess whether the GOLD 2011 strategy is effective in medical practice in Japan. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
fluticasone propionate/salmeterol 50/250mcg, tiotropium bromide 18mcg and fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
407 participants
Where
39 sitesJapan
Study dates
Feb 2013to Sep 2015
Phase
Phase 4
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged 40 - 80 years inclusive
  • Has an established clinical history of COPD (defined as per the GOLD definition)
  • The subject achieves a grade of ≥1 on mMRC at Visit 1
  • A signed and dated written informed consent is obtained from the subject prior to study participation
  • The subject has a post-bronchodilator FEV1 of ≥ 30% to ≤ 80% of predicted normal
  • The subject has a post-bronchodilator FEV1 / FVC ratio < 70%
Show all 9Show fewer
  • The subject is a current or ex-smoker with a smoking history of > 10 pack-years Ex-smokers are required to have stopped smoking for at least 6 months prior to visit 1. Ex-smokers who stopped smoking less than 6 months ago will be defined as current smokers.
  • QTc < 450 msec at Visit 1; or for patients with bundle branch block QTc should be < 480 msec.
  • (QTc(F) < 450 msec, or < 480 msec in subjects with right bundle branch block, should be confirmed by the mean of three readings or one reading) 9. ALT < 2 x ULN and bilirubin/ALP ≤ 1.5 x ULN (> 35% direct bilirubin) 10. A female is eligible to enter this study if she is: i) of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal), or ii) of child-bearing potential, but has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study iii) not a nursing mother

Who cannot join

  • Has a predominant asthma (comorbid asthma is not an exclusion criteria)
  • Has a medical diagnosis of narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction that in the opinion of the investigator should prevent them from entering the study Note: As with other anticholinergic drugs, subjects with narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction should only be entered into the study at the Investigator's discretion
  • Has known respiratory disorders other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis)
  • Has undergone lung surgery e.g., lung transplant and/or lung volume reduction
  • Had a chest X-ray indicating diagnosis other than COPD that might interfere with the study (chest X-ray to be taken at Visit 1, if subject has not had one and/or CT image taken within 3 months of Visit 1)
  • Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as ≥ 12 hours oxygen use per day)
Show all 18Show fewer
  • Has plan to start or to change the pulmonary rehabilitation program during the study period
  • Requires regular treatment with oral, parenteral, or depot corticosteroids
  • Has serious, uncontrolled disease likely to interfere with the study (e.g. Left Ventricular failure, anaemia, renal or hepatic disease or serious psychological disorders)
  • Received any other investigational drugs within 4 weeks (or 5 half lives) prior to Visit 1
  • Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse
  • Has a known or suspected hypersensitivity to β2-agonists, steroids, anticholinergic treatments or any components of the formulations
  • Has previously been enrolled to this study and investigational drugs has been administered
  • Is not eligible to participate this study in the opinion of the investigator/subinvestigator
  • The investigator must refer to the following document(s) for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the investigational product(s) being used in this study:
  • ADOAIR DISKUS package insert
  • Tiotropium/ HandiHaler package insert
  • Salbutamol package insert

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Japan39 sites

  • GSK Investigational Site

    Fukuoka, 814-0180

  • GSK Investigational Site

    Fukuoka, 816-0813

  • GSK Investigational Site

    Hiroshima, 720-0001

  • GSK Investigational Site

    Hiroshima, 734-8530

  • GSK Investigational Site

    Hiroshima, 737-0023

  • GSK Investigational Site

    Hiroshima, 737-0811

  • GSK Investigational Site

    Hokkaido, 070-8644

  • GSK Investigational Site

    Hyōgo, 670-0849

  • GSK Investigational Site

    Ibaraki, 300-0053

  • GSK Investigational Site

    Ibaraki, 302-0022

  • GSK Investigational Site

    Ibaraki, 309-1793

  • GSK Investigational Site

    Ibaraki, 311-3193

  • GSK Investigational Site

    Ibaraki, 319-1113

  • GSK Investigational Site

    Kagawa, 760-0018

  • GSK Investigational Site

    Kagawa, 760-8538

  • GSK Investigational Site

    Kagawa, 761-8073

  • GSK Investigational Site

    Kanagawa, 233-0013

  • GSK Investigational Site

    Kanagawa, 253-0083

  • GSK Investigational Site

    Kochi, 780-0901

  • GSK Investigational Site

    Kyoto, 602-8026

  • GSK Investigational Site

    Kyoto, 610-0113

  • GSK Investigational Site

    Nara, 630-0293

  • GSK Investigational Site

    Niigata, 950-1197

  • GSK Investigational Site

    Niigata, 950-2085

  • GSK Investigational Site

    Niigata, 950-8725

  • GSK Investigational Site

    Okinawa, 901-2132

  • GSK Investigational Site

    Okinawa, 904-2143

  • GSK Investigational Site

    Okinawa, 904-2293

  • GSK Investigational Site

    Osaka, 530-0001

  • GSK Investigational Site

    Osaka, 559-0011

  • GSK Investigational Site

    Osaka, 560-0005

  • GSK Investigational Site

    Osaka, 560-8552

  • GSK Investigational Site

    Saga, 840-8571

  • GSK Investigational Site

    Shizuoka, 434-8511

  • GSK Investigational Site

    Tokyo, 103-0027

  • GSK Investigational Site

    Tokyo, 103-0028

  • GSK Investigational Site

    Tokyo, 158-0083

  • GSK Investigational Site

    Tokyo, 187-8510

  • GSK Investigational Site

    Yamaguchi, 755-0241

Other trials in Japan

About this study

The purpose of this study is to assess the control of COPD using a symptom and exacerbation risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese subjects with COPD and assess whether the GOLD 2011 strategy is effective in medical practice in Japan.

Read the detailed description

PROTOCOL SUMMARY Rationale Both ADOAIR and tiotropium bromide ( hereinafter tiotropium）are now well established, effective treatments for COPD and are frequently co-prescribed (hereinafter TRIPLE therapy). The addition of ADOAIR to tiotropium improves lung function and quality of life and may further reduce exacerbations. GOLD 2011 thus recommends TRIPLE therapy as the second choice of COPD treatment strategy. However, the criteria for switching from each individual treatment to TRIPLE therapy are not clearly shown so far.

This study will be conducted in Japanese subjects with COPD and will assess whether the GOLD 2011 strategy is effective in medical practice in Japan.

Objective(s) The objective of the study is to assess the control of COPD using a symptom and exacerbation risk based treatment strategy based on GOLD 2011.

Study Design Multicenter, randomized, double-dummy, 24-weeks, observational study Study Endpoints/Assessments Primary

  • Proportion of patients who were able to remain on the randomized therapy Secondary
  • Proportion of patients who switched to TRIPLE therapy
  • Proportion of patients who controlled by TRIPLE therapy
  • Proportion of patients controlled by randomized therapy plus TRIPLE therapy
  • Time to switching to TRIPLE therapy
  • Time to first exacerbation
  • Proportion of diagnosed exacerbation confirmed by Daily Record Card
  • Proportion of exacerbations detected by Daily Record Card not diagnosed
  • CAT score change
  • Change in FEV1
  • Use of relief medication
  • Proportion of patients who decreased treatment from TRIPLE therapy
  • Proportion of patients who required additional treatment to TRIPLE therapy
  • Proportion of patients who dropped out
  • Patients' judgment of treatment efficacy
  • Physician's judgment of treatment efficacy

Safety

  • Adverse event reporting
  • Exacerbations of COPD
Being tested
fluticasone propionate/salmeterol 50/250mcg, fluticasone propionate/salmeterol placebo, tiotropium bromide 18mcg, tiotropium bromide placebo, fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg
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.

  • fluticasone propionate/salmeterol 50/250mcgDrug

    Also called ADOAIR is a registered trade mark of the GlaxoSmithKline group of companies

    Active, 50/250mcg, Twice daily (morning and evening)

  • fluticasone propionate/salmeterol placeboDrug

    Placebo, Twice daily (morning and evening)

  • tiotropium bromide 18mcgDrug

    Active, 18mcg, Once daily(morning)

  • tiotropium bromide placeboDrug

    Placebo, Once daily(morning)

  • fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcgDrug

    Also called TRIPLE therapy

    Active. The randomized treatment may be switched to TRIPLE therapy when COPD symptoms are uncontrolled or the subject is not satisfied with the randomized treatment at each scheduled or unscheduled visit.

Study groups in NCT01762800
Study groupRoleWhat they receive
fluticasone propionate/salmeterolExperimentalRandomised treatment at Visit 2
Receives: Drug: fluticasone propionate/salmeterol 50/250mcg; Drug: tiotropium bromide placebo; Drug: fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg
tiotropium bromideExperimentalRandomised treatment at Visit 2
Receives: Drug: fluticasone propionate/salmeterol placebo; Drug: tiotropium bromide 18mcg; Drug: fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg

What is being measured

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

  1. Percentage of Participants Who Were Able to Remain on the Randomized Treatment

    The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) is not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. The percentage of participants who were able to remain on the randomized treatment was calculated by the following formula: 100 minus percentage of participants who switched over to TRIPLE therapy.

    Measured: 24 weeks

Secondary outcomes (20)

  1. Percentage of Participants Who Switched to TRIPLE Therapy

    Switched to TRIPLE therapy is defined as: 1. Date of switch: when SAL/FLU or TIO was administered additionally to randomised treatment. 2. Date of randomisation was a start point and timing of switching (first switch if there are more than once) to TRIPLE was event. For participants without switching, last day of study or follow up period was regarded as censored. Percentage of participants who switched to TRIPLE therapy was calculated as: number of participants who switched to TRIPLE therapy divided by number of evaluable population and then multiplied by 100.

    Measured: 24 weeks

  2. Percentage of Participants Managed by TRIPLE Therapy

    Percentage of participants managed by TRIPLE therapy was calculated as [(number of participants who switched to TRIPLE therapy) - (number of participants who stepped down)/ number of evaluable population]*100

    Measured: 24 weeks

  3. Continuation Percentage of Participants Managed by Randomized Treatment Plus TRIPLE Therapy

    The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) was not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. Continuation TRIPLE proportion is defined as [(number of subjects who switched to TRIPLE) - (number of subjects who stepped down)/ number of evaluable population]*100. Randomised treatment continuation proportion is calculated by a formula: (100 - switch proportion).

    Measured: 24 weeks

  4. Time to First Switching to TRIPLE Therapy

    The day of first switch to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) for the first switching participant in each arm.

    Measured: 24 weeks

  5. Time to First Exacerbation by Physician's Diagnosis

    The day of detection of first exacerbation in any participant in each arm as diagnosed by physician. Exacerbation is defined primarily by physician's judgment. Date of randomisation will be start point and timing of exacerbation (first exacerbation if there are more than one) will be event. For subjects without exacerbation, last day of study or follow up period is regarded as censor.

    Measured: 24 weeks

  6. Time to First Exacerbation by EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)

    The EXAcerbations of Chronic pulmonary disease Tool (EXACT) is a 14-item patient-reported outcome (PRO) daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Reported as units on a 0 [best health status] to 100 [worst possible status] scale). The day of detection of first exacerbation in any participant in each arm by EXACT.

    Measured: 24 weeks

  7. EXACT Total Score.

    EXACT is a 14-item patient questionnaire used as a measure of respiratory symptoms (reported as units on a 0 [best health status] to 100 [worst possible status] scale). Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.

    Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores.

    Measured: Baseline and up to 24 weeks

  8. EXACT Respiratory Symptoms (E-RS) Total Score

    The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.

    Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. Scores range from 0-100, high value in score indicate worse outcome.

    Measured: Baseline and up to 24 weeks

  9. E-RS Subscale Score

    The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. The E-RS subscale scores for respiratory symptoms (RS)-breathlessness (RS-BRL), RS-cough and sputum (RS-CSP), and RS-chest symptoms (RS-CSY) are presented. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score. Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. RS total scores range from 0 to 40, high value in score indicate worse outcome.

    Measured: 24 weeks

  10. Comparison of Number of Exacerbations Between Two Detection Methods: EXACT and Physician Diagnosis

    The comparison of number of exacerbation between two detection methods EXACT and physician diagnosis: number of exacerbations detected by EXACT and number of exacerbations judged by physician.

    Measured: 24 weeks

  11. Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Total Score

    Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Scores were assessed at Visit 1 (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.

    Measured: 24 weeks

  12. Change From Baseline in CAT Total Score

    Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Baseline was the value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. Scores were assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.

    Measured: Baseline and up to 24 weeks

  13. Forced Expiratory Volume in One Second (FEV1)

    FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. At Screening (Visit 1) spirometric assessments were conducted before (Visit 1A) and 30 to 60 minutes after a bronchodilator challenge (400 µg of salbutamol) (Visit 1B). FEV1 during each visit are presented. FEV1 was assessed at Visit 1A (Screening), Visit 1B (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).

    Measured: Up to 24 weeks

  14. Change From Baseline in FEV1

    FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. Baseline was a value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. FEV1 was assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).

    Measured: Baseline (Visit 2) and up to 24 weeks

  15. Percentage of Participants Who Used Relief Medication (Salbutamol)

    Each evening participants recorded the number of occasions in the last 24 hours when they used their salbutamol for symptomatic relief of COPD symptoms. The percentage of participants who used relief medication in the study are presented.

    Measured: 24 weeks

  16. Percentage of Participants Who Stepped Down From TRIPLE Therapy to Initial Randomized Treatment

    The percentage of participants who stepped down from TRIPLE therapy to initial randomized treatment was calculated as number of participants who step-down from TRIPLE therapy divided by number of participants who switch to TRIPLE therapy and then multiplied by 100.

    Measured: 24 weeks

  17. Percentage of Participants Who Required Additional Treatment to TRIPLE Therapy

    The percentage of participants who required additional treatment to TRIPLE therapy is defined as number of participants who took additional medicine or therapy in TRIPLE therapy divided by number of participants who switch to TRIPLE therapy multiplied by 100.

    Measured: 24 weeks

  18. Percentage of Participants Who Dropped Out

    The percentage of participants who were withdrawn from the study.

    Measured: 24 weeks

  19. Number of Participants in Each Treatment Efficacy Grade Evaluated by Participants

    Participants evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).

    Measured: Up to 24 weeks

  20. Number of Participants in Each Treatment Efficacy Grade Evaluated by Physician

    Physician evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).

    Measured: 24 weeks

Timeline

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

  1. First posted8 Jan 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionSep 2015
  4. Study completionSep 2015

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01762800
Sponsor's protocol ID
116717
Status last verified
Aug 2016
First submitted
6 Dec 2012
Last updated
10 Nov 2016
Data monitoring committee
No

Publications

  • Betsuyaku T, Kato M, Fujimoto K, Hagan G, Kobayashi A, Hitosugi H, James M, Jones PW. A study to assess COPD Symptom-based Management and to Optimise treatment Strategy in Japan (COSMOS-J) based on GOLD 2011. Int J Chron Obstruct Pulmon Dis. 2013;8:453-9. doi: 10.2147/COPD.S48298. Epub 2013 Oct 3.

    PubMed 24124358

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fluticasone propionate/salmeterol 50/250mcg, tiotropium bromide 18mcg and fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 39 sites in Japan.

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 9 inclusion and 18 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 10 Nov 2016). 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?

Percentage of Participants Who Were Able to Remain on the Randomized Treatment (time frame: 24 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 NCT01762800, 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 10 Nov 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in