Rhinitis, VasomotorPhase 3NCT00117325
Study Of Adults And Adolescents With Vasomotor Rhinitis
A Phase 3 study testing GW685698X in people with Rhinitis, Vasomotor, run by GlaxoSmithKline at 53 sites in 6 countries.
Trial summary
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Vasomotor
- What is being tested?
- GW685698X
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 53 sitesin 6 countries
- Study dates
- 11 Jul 2005to 9 Feb 2006
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be outpatients.
- Diagnosis of VMR.
- Literate in English or native language.
Who cannot join
- Significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
- Used tobacco products within the past year.
Trial locations and contacts
53 sites in 6 countries.
53 sites in 6 countries
United States38 sites
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Bangor, Maine, 04401
GSK Investigational Site
Beverly Hills, California, 90212
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Easton, Pennsylvania, 18042
GSK Investigational Site
Englewood, Colorado, 80112
GSK Investigational Site
Evansville, Indiana, 47713
GSK Investigational Site
Fort Collins, Colorado, 80526
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Knoxville, Tennessee, 37922
GSK Investigational Site
Lake Oswego, Oregon, 97035
GSK Investigational Site
Liverpool, New York, 13088
GSK Investigational Site
Louisville, Kentucky, 40207
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Mount Laurel, New Jersey, 08054
GSK Investigational Site
North Olmsted, Ohio, 44070
GSK Investigational Site
Novi, Michigan, 48375
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Palmyra, Pennsylvania, 17078
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Portland, Oregon, 97213
GSK Investigational Site
Rochester, New York, 14618
GSK Investigational Site
Rockville, Maryland, 20850
GSK Investigational Site
Salt Lake City, Utah, 84102
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
Santa Barbara, California, 93105
GSK Investigational Site
Shreveport, Louisiana, 71104
GSK Investigational Site
Upland, Pennsylvania, 19013
GSK Investigational Site
Woodstock, Georgia, 30188
GSK Investigational Site
Ypsilanti, Michigan, 48197
Germany5 sites
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502
GSK Investigational Site
Hamburg, 20249
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Kassel, Hesse, 34117
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
Canada3 sites
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5
GSK Investigational Site
Kelowna, British Columbia, V1Y 9L8
GSK Investigational Site
Québec, G1V 4M6
Czechia3 sites
GSK Investigational Site
Litoměřice, 412 01
GSK Investigational Site
Olomouc, 775 25
GSK Investigational Site
Tábor, 390 19
Norway2 sites
GSK Investigational Site
Larvik, N-3256
GSK Investigational Site
Nesttun, N-5227
Romania2 sites
GSK Investigational Site
Bucharest
GSK Investigational Site
Deva, 2700
About this study
Official title: A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
- Conditions
- Rhinitis, Vasomotor
- Being tested
- GW685698X
- Keywords
- Vasomotor Rhinitis, VMR, nonallergic rhinitis, GW685698X
- Medical subject headings
- Rhinitis, Vasomotor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW685698XDrug
Aqueous Nasal Spray 100mcg
| Study group | Role | What they receive |
|---|---|---|
| GW685698X | Experimental | GW685698X Receives: Drug: GW685698X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)
The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary outcomes (11)
Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)
The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Number of Participants With Overall Evaluation of Response to Therapy
The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse.
Measured: Up to 4 weeks
Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS
The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS
The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS
The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS
The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip
The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Scores Changes From Baseline as a Function of Time
The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Measured: Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2005 (estimated)
- Study start11 Jul 2005
- Primary completion9 Feb 2006
- Study completion9 Feb 2006
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.
- Other trials for Rhinitis, VasomotorStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Parallel groups
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117325
- Sponsor's protocol ID
- FFR30006
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2005
- Last updated
- 13 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis
- ClinicalTrials.gov ID
- NCT00117325
- Acronym / sponsor ID
- FFR30006
- Conditions
- Rhinitis, Vasomotor
- Keywords
- Vasomotor Rhinitis, VMR, nonallergic rhinitis, GW685698X
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2005 (actual)
- Primary completion
- 9 Feb 2006 (actual)
- Study completion
- 9 Feb 2006 (actual)
- First posted
- 6 Jul 2005 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GW685698X | Experimental | Drug: GW685698XGW685698X |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Must be outpatients.
- Diagnosis of VMR.
- Literate in English or native language.
Key exclusion criteria (3 listed)
- Significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
- Used tobacco products within 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 |
|---|---|---|
| GW685698XAqueous Nasal Spray 100mcg | Drug | GW685698X |
Primary outcome
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
11 secondary outcomes
Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Number of Participants With Overall Evaluation of Response to Therapy
Time frame: Up to 4 weeks
Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Scores Changes From Baseline as a Function of Time
Time frame: Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
53 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GW685698X in people with Rhinitis, Vasomotor, run by GlaxoSmithKline at 53 sites in 6 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 3 inclusion and 3 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Germany, Canada, Czechia, Norway and 1 more country. 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 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 13 Mar 2018). 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?
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) (time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2018.