RhinitisPhase 4NCT01469234

A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)

A Phase 4 study testing loratadine and fexofenadine in people with Rhinitis, run by Bayer.

Completed

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

Trial summary

The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rhinitis
What is being tested?: loratadine and fexofenadine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 255 participants
Where: No sites listed yet
Study dates: Oct 2011to Nov 2011
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female participants of child bearing potential must demonstrate a negative
urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study.
Willing to stop use of current decongestant and allergy medications at the start of the washout period (Visit 1) and during the trial.
Documented history or participant-reported history of seasonal allergic rhinitis caused by mountain cedar pollen within the last 2 years and documented or participant-reported symptoms over at least the last 2 mountain cedar allergy seasons.
Documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the last 1 year to mountain cedar pollen present.
Capable of reading English.
Body mass index (BMI) <35.

Who cannot join

Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, fexofenadine or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.
Have started allergen immunotherapy within 1 month preceding enrollment or participants starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.
Known allergy or intolerance to loratadine, desloratadine, or fexofenadine.
History of rhinitis medicamentosa.
Use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone is permitted), or nasal corticosteroids in the last 30 days or current or expected use of disallowed medications as listed in the protocol.
Asthma, with the exception of mild intermittent asthma.

About this study

Official title: A Double-Blind, Parallel, Randomized, Placebo Controlled Trial to Evaluate Onset of Action of Loratadine and Fexofenadine in Subjects With Seasonal Allergic Rhinitis in a Pollen Challenge Chamber

The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and

Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.

Conditions: Rhinitis
Being tested: loratadine, fexofenadine, placebo to loratadine, placebo to fexofenadine
Medical subject headings: Rhinitis

What participants receive

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

loratadineDrug
Also called SCH 029851
loratadine, one 10 mg tablet, orally
fexofenadineDrug
fexofenadine, one 180 mg tablet, orally
placebo to loratadineDrug
one tablet, orally
placebo to fexofenadineDrug
one tablet, orally

Study groups in NCT01469234
Study group	Role	What they receive
loratadine	Experimental	Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Receives: Drug: loratadine; Drug: placebo to fexofenadine
fexofenadine	Experimental	Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Receives: Drug: fexofenadine; Drug: placebo to loratadine
placebo	Placebo comparator	Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4. Receives: Drug: placebo to loratadine; Drug: placebo to fexofenadine

What is being measured

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

Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.
Measured: From time of sensitization (time 0) to end of visit (~8 hours)

Secondary outcomes (7)

Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
The individual symptom score for Runny Nose was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Measured: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
The individual symptom score for Itchy Nose was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Measured: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
The individual symptom score for Sneezing was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Measured: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
The individual symptom score for Water Eyes was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Measured: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
The individual symptom score for Itchy Eyes was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Measured: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
The individual symptom score for Nasal Congestion was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Measured: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Measured: From time of sensitization (time 0) to end of visit (~8 hours)

Timeline

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

Oct 2011Nov 2011

First posted10 Nov 2011 (estimated)
Study startOct 2011
Primary completionNov 2011
Study completionNov 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.
Other trials for RhinitisStudies of the same condition, open and under way.
More trials run by BayerThe 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01469234
Sponsor's protocol ID: 18126
Other IDs: PT11-37, P08712
Status last verified: Feb 2015
First submitted: 8 Nov 2011
Last updated: 11 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

Official record

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
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Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis

All Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Parallel, Randomized, Placebo Controlled Trial to Evaluate Onset of Action of Loratadine and Fexofenadine in Subjects With Seasonal Allergic Rhinitis in a Pollen Challenge Chamber
ClinicalTrials.gov ID: NCT01469234
Acronym / sponsor ID: 18126
Conditions: Rhinitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 255 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 10 Nov 2011 (estimated)
Results: Posted 22 Mar 2013

Clinical summary

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

The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
loratadine	Experimental	Drug: loratadine, Drug: placebo to fexofenadineParticipants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
fexofenadine	Experimental	Drug: fexofenadine, Drug: placebo to loratadineParticipants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
placebo	Placebo comparator	Drug: placebo to loratadine, Drug: placebo to fexofenadineParticipants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Female participants of child bearing potential must demonstrate a negative
urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study.
Willing to stop use of current decongestant and allergy medications at the start of the washout period (Visit 1) and during the trial.
Documented history or participant-reported history of seasonal allergic rhinitis caused by mountain cedar pollen within the last 2 years and documented or participant-reported symptoms over at least the last 2 mountain cedar allergy seasons.
Documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the last 1 year to mountain cedar pollen present.

Key exclusion criteria (6 listed)

Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, fexofenadine or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.
Have started allergen immunotherapy within 1 month preceding enrollment or participants starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.
Known allergy or intolerance to loratadine, desloratadine, or fexofenadine.
History of rhinitis medicamentosa.
Use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone is permitted), or nasal corticosteroids in the last 30 days or current or expected use of disallowed medications as listed in the protocol.

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
loratadineAlso: SCH 029851loratadine, one 10 mg tablet, orally	Drug	loratadine
fexofenadinefexofenadine, one 180 mg tablet, orally	Drug	fexofenadine
placebo to loratadineone tablet, orally	Drug	fexofenadine, placebo
placebo to fexofenadineone tablet, orally	Drug	loratadine, placebo

Primary outcome

Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
Time frame: From time of sensitization (time 0) to end of visit (~8 hours)
The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.

7 secondary outcomes

Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
Time frame: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
Time frame: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
Time frame: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
Time frame: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
Time frame: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
Time frame: From time of sensitization (time 0) to end of visit (~8 hours)
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
Time frame: From time of sensitization (time 0) to end of visit (~8 hours)

Results and safety

Results posted to the registry on 22 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Loratadine	85	85
Fexofenadine	85	85
Placebo	85	85

Primary outcome: Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)

Time frame: From time of sensitization (time 0) to end of visit (~8 hours). Mean (Standard Deviation). Unit: units on a scale

Measure	Loratadine n = 85	Fexofenadine n = 85	Placebo n = 85
180 minutes (n=85, n=85, n=85)	7.4 (4.51)	6.7 (4.86)	8.5 (5.07)
195 minutes (n=85, n=85, n=85)	7.5 (4.84)	6.7 (4.87)	8.9 (5.31)
210 minutes (n=85, n=85, n=85)	7.3 (4.73)	6.5 (4.87)	8.7 (5.28)
225 minutes (n=85, n=85, n=85)	7.4 (4.63)	6.5 (4.70)	8.5 (5.36)
240 minutes (n=84, n=85, n=85)	7.4 (4.76)	6.5 (4.43)	8.3 (5.38)
255 minutes (n=85, n=85, n=85)	7.1 (4.78)	6.3 (4.47)	8.4 (5.51)
270 minutes (n=85, n=85, n=85)	7.0 (4.67)	6.4 (4.50)	8.4 (5.56)
285 minutes (n=85, n=85, n=85)	7.3 (4.52)	6.9 (4.76)	8.7 (5.76)

Population analysed: Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loratadine	0 of 85 (0%)	0 of 85 (0%)	Not reported
Fexofenadine	0 of 85 (0%)	0 of 85 (0%)	Not reported
Placebo	0 of 85 (0%)	0 of 85 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rhinitis

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing loratadine and fexofenadine in people with Rhinitis, run by Bayer.

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 7 inclusion and 6 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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 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 22 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) (time frame: From time of sensitization (time 0) to end of visit (~8 hours)). 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 NCT01469234.

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 11 Mar 2015.