Rhinitis MedicamentosaPhase 4MomestasoneNCT04898764
Research on Underlying Causes of Long-term Use of Nasal Decongestants and the Structured Withdrawal of the Decongestant
A Phase 4 study testing Mometasone Furoate in people with Rhinitis Medicamentosa, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Rhinitis medicamentosa (RM) is a form of non-allergic medication-induced rhinitis characterised by nasal congestion. This nasal congestion is the result of the overuse of intranasal decongestants which leads to rebound congestion when the medication wears off. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhinitis Medicamentosa
- What is being tested?
- Mometasone Furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Oct 2020to 30 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria Healthy Volunteers (only included in part A of the study):
- Aged 18 years or older
- Sufficient knowledge of the Dutch language
Exclusion Criteria Healthy Volunteers (only included in part A of the study):
- Subjective presence of nasal disease (i.e. the study subject indicates to experience any nasal symptoms, an occasional common cold not taken into account)
- Established diagnosis of a nasal disorder (e.g. allergy, nasal polyps, …) or a positive allergy test (skin prick test or blood test)
- Prior nasal surgery
- Asthma
- Use of an oral corticosteroid in the month prior to the screening visit
- Significant disease(s) that might interfere with the study, based on the judgement of the investigator
- Current use of a nasal decongestant, more than two episodes of 7 days use of a nasal decongestant in the previous year or less than two episodes of 7 days use (in the previous year) but last use less than a month prior to the screening visit
- Other medication used to treat nasal symptoms (intranasal corticosteroids, oral or intranasal antihistamines, oral decongestants …)
- History of rhinitis medicamentosa (either patient-reported long-term use of a nasal decongestant or a diagnosis of rhinitis medicamentosa)
- Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
Inclusion Criteria patients with long-term use of nasal decongestants: part A:
- Aged 18 years or older
- Daily use of a nasal decongestant for at least 6 months. Following ATC-codes are considered, when the spray or drops contain a nasal decongestant and the drug is thus intended for short-term use only: R01AA, R01AB, R01AD52, R01AD53
- Sufficient knowledge of the Dutch language
Exclusion Criteria patients with long-term use of nasal decongestants: part A:
- Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Use of an oral corticosteroid in the month prior to the screening visit
- Use of an oral decongestant in the week prior to the screening visit
- Significant disease(s) that might interfere with the study, based on the judgement of the investigator
Inclusion Criteria patients with long-term use of nasal decongestants: part B:
- Aged 18 years or older
- Daily use of a nasal decongestant for at least 6 months.Following ATC-codes are considered, when the spray or drops contain a nasal decongestant and the drug is thus intended for short-term use only: R01AA, R01AB, R01AD52, R01AD53
- Sufficient knowledge of the Dutch language
Exclusion Criteria patients with long-term use of nasal decongestants: part B:
- Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Glaucoma
- Use of an oral corticosteroid in the month prior to the start of the intervention
- Use of an oral decongestant in the week prior to the start of the intervention
- Significant disease(s) that might interfere with the study, based on the judgement of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation and Intervention Study in Patients With Long-term Use of Nasal Decongestants
Rhinitis medicamentosa (RM) is a form of non-allergic medication-induced rhinitis characterised by nasal congestion. This nasal congestion is the result of the overuse of intranasal decongestants which leads to rebound congestion when the medication wears off. This prompts the user of the nasal decongestant to administer more in order to obtain relief from the feeling of a blocked nose. Therefore, the patient ends up in a vicious cycle caused and temporarily relieved by the use of medication.The diagnosis of rhinitis medicamentosa depends greatly on the history of prolonged use of the nasal decongestant, since real diagnostic criteria have not yet been established. It is unclear if these patients suffer from an underlying (undetected and/or untreated) nasal condition which might have caused the patient to start using the nasal decongestant in the first place. Therefore, the aim of the first part of this study (Part A) is to characterize patients with long-term use of nasal decongestants to examine if an underlying nasal condition is present. The investigators will include healthy volunteers in part A of the study to be able to compare their test results with those of patients with long-term use of nasal decongestants and hence be able to detect differences.
Thus far, the treatment of RM has been the topic of debate. Several treatment regimens have been proposed in literature, but most study authors agree that it is essential to stop the overuse of the nasal decongestant either immediately or gradually to limit withdrawal symptoms. For this part of the study (Part B: intervention study), the investigators aim to reduce the long-term use of nasal decongestants based on a structured withdrawal programme comprising medication (nasal corticosteroid spray) and motivational interviewing. Only patients with long-term use of nasal decongestants are eligible to participate in this part of the study. They will be rescreened prior to inclusion into this part of the study.
Read the detailed description
The study comprises two parts:
- Part A: Characterisation study (both healthy volunteers and patients with long-term use of nasal decongestants)
- Part B: Intervention study (only patients with long-term use of nasal decongestants). Patients will be rescreened prior to inclusion into part B of the study. Participants will receive the intervention (Mometasone furoate nasal spray) during a 12-week period
Part A (characterisation study) consists of three study-related contact moments:
- Screening visit
- Telephone contact
- Ear-, nose- and throat examination (actual characterisation study)
Part B (intervention study) consists of five contact moments:
- Start-up of the intervention
- Telephone contact (during follow-up 1 period)
- Follow-up 1 (After 6 weeks of intervention*)
- Follow-up 2 (After 12 weeks of intervention*)
- Telephone follow-up (6 months post start-up of the intervention*) * Study windows foreseen in the protocol
Procedures performed during part A of the study:
- Peak Nasal Inspiratory Flow (PNIF) measurements
- Nasal endoscopy
- Collection of blood samples and nasal secretions
- Completion of questionnaires
- Completion of patient diary
- Collection of data regarding medication use
- Skin prick testing
- Completion of patient diary
- Medical photography of the face and nose
- Telephone follow-up
Procedures performed during part B of the study:
- Urine pregnancy test
- Collection of data regarding medication use
- Counselling conversations with the researchers
- Completion of questionnaires
- Completion of patient diary
- Drug accountability
- Daily administration of Mometasone furoate (by the patients themselves, during a 12 week period)
- PNIF measurements
- Nasal endoscopy
- Collection of blood samples and nasal secretions
- Telephone follow-up
- Conditions
- Rhinitis Medicamentosa
- Being tested
- Mometasone Furoate
- Keywords
- non-allergic drug-induced rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone FuroateDrug
Mometasone furoate nasal spray suspension, 50µg/actuation
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | No intervention | This study arm will only participate in part A of the study (Characterisation study) and thus will not receive the study drug. A maximum of 35 healthy volunteers will be included in this study arm. |
| Patients with long-term use of nasal decongestants | Experimental | A maximum of 100 patients with long-term use of nasal decongestants will be included in this study arm, for part A of the study (Characterisation study).
The investigators will consecutively recruit patients from part A (Characterisation study) into part B of the study (Intervention study) until a total of 35 patients completed all study-related visits of part B. During the intervention study, patients with long-term use of nasal decongestants will administer Mometasone furoate intranasally, two doses (50µg/actuation) in each nostril, twice daily (total daily dose of 400µg) during a 12 week period. Receives: Drug: Mometasone Furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study subjects with long-term use of nasal decongestants able to completely withdraw the use of the nasal decongestant after 12 weeks of intervention.
To evaluate the effectiveness of a standardized, structured withdrawal plan based on Mometasone furoate combined with motivational interviewing to reduce the overuse of nasal decongestants.
For this study, complete withdrawal is defined as at least 7 consecutive days without any use of a nasal decongestant.
Measured: Assessed at follow-up 2 (12 weeks post start up intervention)
Proportion of study subjects who were able to completely withdraw the long-term use of nasal decongestants at follow-up 2 (after 12 weeks of intervention) who relapsed by the time of follow-up 3 (6 months after the start-up of the intervention).
To evaluate the relapse rates of patients with former nasal decongestant overuse. For this study, relapse is defined as daily use of a nasal decongestant for more than 7 consecutive days after prior full withdrawal of the nasal decongestant
Measured: Assessed at follow-up 3 (6 months post start-up of the intervention)
Secondary outcomes (8)
Change from intervention baseline (part B) to week 12 of intervention in Rhinitis Control Assessment Test (RCAT) score (RCAT scores range from 6 to 30, with higher scores indicating greater rhinitis symptom control)
To evaluate the change in rhinitis control due to the withdrawal of the nasal decongestant
Measured: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)
Change from intervention baseline (part B) to week 12 of intervention in home measured PNIF as captured in diary on a fixed day every week
To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant
Measured: Assessed during screening period (2 weeks) and intervention period (12 weeks post start up intervention) on a weekly basis
Change from intervention baseline (part B) to week 12 of intervention in hospital measured Peak Nasal Inspiratory Flow (PNIF)
To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant
Measured: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)
Change from intervention baseline (part B) to week 12 of intervention in Visual Analogue Scale (VAS) for nasal obstruction. Range 0mm - 100mm with higher values indicating worse outcome
To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant
Measured: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)
Change from intervention baseline (part B) to week 12 of intervention in Visual Analogue Scale (VAS) for nasal symptoms (nasal obstruction, runny nose, sneezing) as captured in the daily diary. Range 0mm-100mm with higher values indicating worse outcome
To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant
Measured: Assessed during screening period (2 weeks) and intervention period (12 weeks) on a daily basis
Change from intervention baseline (part B) to week 12 of intervention in Mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) (14 items, 0= no impairment to 6= severely impaired; higher scores indicate greater impairment of QoL)
To evaluate the change in disease specific health-related quality of life (HRQoL) due to the withdrawal of the nasal decongestant
Measured: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start up intervention)
Change from intervention baseline (part B) to week 12 of intervention in PROMIS Sleep Disturbance Short form 8b scores (Raw scores range from 8 to 40, with higher scores indicating greater sleep disturbance)
To evaluate the change in sleep disturbance due to the withdrawal of the nasal decongestant
Measured: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)
Change from baseline (part A) to week 12 of intervention in nasal endoscopy outcomes, assessed with our newly developed nasal endoscopy scoring sheet (containing Visual Analogue Scales (0-100mm), a colour scale and a nasal polyp scoring system)
To evaluate the change in nasal endoscopy outcomes due to the withdrawal of the nasal decongestant
Measured: Assessed at baseline (characterisation study) and at follow-up 2 (12 weeks post start-up intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start21 Oct 2020
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis MedicamentosaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Gevaert, MD, PhD, Principal investigator, Ghent University Hospital, Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898764
- Sponsor's protocol ID
- AGO/2019/005
- Other IDs
- 2019-003254-91, 2019
- Acronym
- Momestasone
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2020
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation and Intervention Study in Patients With Long-term Use of Nasal Decongestants
- ClinicalTrials.gov ID
- NCT04898764
- Acronym / sponsor ID
- Momestasone / AGO/2019/005
- Conditions
- Rhinitis Medicamentosa
- Keywords
- non-allergic drug-induced rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rhinitis medicamentosa (RM) is a form of non-allergic medication-induced rhinitis characterised by nasal congestion. This nasal congestion is the result of the overuse of intranasal decongestants which leads to rebound congestion when the medication wears off. This prompts the user of the nasal decongestant to administer more in order to obtain relief from the feeling of a blocked nose. Therefore, the patient ends up in a vicious cycle caused and temporarily relieved by the use of medication.The diagnosis of rhinitis medicamentosa depends greatly on the history of prolonged use of the nasal decongestant, since real diagnostic criteria have not yet been established. It is unclear if these patients suffer from an underlying (undetected and/or untreated) nasal condition which might have caused the patient to start using the nasal decongestant in the first place. Therefore, the aim of the first part of this study (Part A) is to characterize patients with long-term use of nasal decongestants to examine if an underlying nasal condition is present. The investigators will include healthy volunteers in part A of the study to be able to compare their test results with those of patients with long-term use of nasal decongestants and hence be able to detect differences.
Thus far, the treatment of RM has been the topic of debate. Several treatment regimens have been proposed in literature, but most study authors agree that it is essential to stop the overuse of the nasal decongestant either immediately or gradually to limit withdrawal symptoms. For this part of the study (Part B: intervention study), the investigators aim to reduce the long-term use of nasal decongestants based on a structured withdrawal programme comprising medication (nasal corticosteroid spray) and motivational interviewing. Only patients with long-term use of nasal decongestants are eligible to participate in this part of the study. They will be rescreened prior to inclusion into this part of the study.
Detailed description
The study comprises two parts:
- Part A: Characterisation study (both healthy volunteers and patients with long-term use of nasal decongestants)
- Part B: Intervention study (only patients with long-term use of nasal decongestants). Patients will be rescreened prior to inclusion into part B of the study. Participants will receive the intervention (Mometasone furoate nasal spray) during a 12-week period
Part A (characterisation study) consists of three study-related contact moments:
- Screening visit
- Telephone contact
- Ear-, nose- and throat examination (actual characterisation study)
Part B (intervention study) consists of five contact moments:
- Start-up of the intervention
- Telephone contact (during follow-up 1 period)
- Follow-up 1 (After 6 weeks of intervention*)
- Follow-up 2 (After 12 weeks of intervention*)
- Telephone follow-up (6 months post start-up of the intervention*) * Study windows foreseen in the protocol
Procedures performed during part A of the study:
- Peak Nasal Inspiratory Flow (PNIF) measurements
- Nasal endoscopy
- Collection of blood samples and nasal secretions
- Completion of questionnaires
- Completion of patient diary
- Collection of data regarding medication use
- Skin prick testing
- Completion of patient diary
- Medical photography of the face and nose
- Telephone follow-up
Procedures performed during part B of the study:
- Urine pregnancy test
- Collection of data regarding medication use
- Counselling conversations with the researchers
- Completion of questionnaires
- Completion of patient diary
- Drug accountability
- Daily administration of Mometasone furoate (by the patients themselves, during a 12 week period)
- PNIF measurements
- Nasal endoscopy
- Collection of blood samples and nasal secretions
- Telephone follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | No intervention | –This study arm will only participate in part A of the study (Characterisation study) and thus will not receive the study drug. A maximum of 35 healthy volunteers will be included in this study arm. |
| Patients with long-term use of nasal decongestants | Experimental | Drug: Mometasone FuroateA maximum of 100 patients with long-term use of nasal decongestants will be included in this study arm, for part A of the study (Characterisation study). The investigators will consecutively recruit patients from part A (Characterisation study) into part B of the study (Intervention study) until a total of 35 patients completed all study-related visits of part B. During the intervention study, patients with long-term use of nasal decongestants will administer Mometasone furoate intranasally, two doses (50µg/actuation) in each nostril, twice daily (total daily dose of 400µg) during a 12 week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Mometasone FuroateMometasone furoate nasal spray suspension, 50µg/actuation | Drug | Patients with long-term use of nasal decongestants |
Primary outcome
Proportion of study subjects with long-term use of nasal decongestants able to completely withdraw the use of the nasal decongestant after 12 weeks of intervention.
Time frame: Assessed at follow-up 2 (12 weeks post start up intervention)
To evaluate the effectiveness of a standardized, structured withdrawal plan based on Mometasone furoate combined with motivational interviewing to reduce the overuse of nasal decongestants. For this study, complete withdrawal is defined as at least 7 consecutive days without any use of a nasal decongestant.
Proportion of study subjects who were able to completely withdraw the long-term use of nasal decongestants at follow-up 2 (after 12 weeks of intervention) who relapsed by the time of follow-up 3 (6 months after the start-up of the intervention).
Time frame: Assessed at follow-up 3 (6 months post start-up of the intervention)
To evaluate the relapse rates of patients with former nasal decongestant overuse. For this study, relapse is defined as daily use of a nasal decongestant for more than 7 consecutive days after prior full withdrawal of the nasal decongestant
8 secondary outcomes
Change from intervention baseline (part B) to week 12 of intervention in Rhinitis Control Assessment Test (RCAT) score (RCAT scores range from 6 to 30, with higher scores indicating greater rhinitis symptom control)
Time frame: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)
Change from intervention baseline (part B) to week 12 of intervention in home measured PNIF as captured in diary on a fixed day every week
Time frame: Assessed during screening period (2 weeks) and intervention period (12 weeks post start up intervention) on a weekly basis
Change from intervention baseline (part B) to week 12 of intervention in hospital measured Peak Nasal Inspiratory Flow (PNIF)
Time frame: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)
Change from intervention baseline (part B) to week 12 of intervention in Visual Analogue Scale (VAS) for nasal obstruction. Range 0mm - 100mm with higher values indicating worse outcome
Time frame: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)
Change from intervention baseline (part B) to week 12 of intervention in Visual Analogue Scale (VAS) for nasal symptoms (nasal obstruction, runny nose, sneezing) as captured in the daily diary. Range 0mm-100mm with higher values indicating worse outcome
Time frame: Assessed during screening period (2 weeks) and intervention period (12 weeks) on a daily basis
Change from intervention baseline (part B) to week 12 of intervention in Mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) (14 items, 0= no impairment to 6= severely impaired; higher scores indicate greater impairment of QoL)
Time frame: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start up intervention)
Change from intervention baseline (part B) to week 12 of intervention in PROMIS Sleep Disturbance Short form 8b scores (Raw scores range from 8 to 40, with higher scores indicating greater sleep disturbance)
Time frame: Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)
Change from baseline (part A) to week 12 of intervention in nasal endoscopy outcomes, assessed with our newly developed nasal endoscopy scoring sheet (containing Visual Analogue Scales (0-100mm), a colour scale and a nasal polyp scoring system)
Time frame: Assessed at baseline (characterisation study) and at follow-up 2 (12 weeks post start-up intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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.
Philippe Gevaert, MD, PhD principal investigator
Ghent University Hospital, Ghent, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mometasone Furoate in people with Rhinitis Medicamentosa, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of study subjects with long-term use of nasal decongestants able to completely withdraw the use of the nasal decongestant after 12 weeks of intervention. (time frame: Assessed at follow-up 2 (12 weeks post start up intervention)). The study lists 2 primary outcomes in all. 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 28 Jan 2026.