Rhinitis, Allergic, PerennialPhase 3NCT01700192

Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

A Phase 3 study testing MK-8237 tablets, Rescue Medication: Self-Injectable Epinephrine and Rescue Medication: Loratadine tablets in people with Rhinitis, Allergic, Perennial and Rhinitis, Allergic, Nonseasonal, run by ALK-Abelló A/S.

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 efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Nonseasonal
What is being tested?: MK-8237 tablets, Rescue Medication: Self-Injectable Epinephrine and Rescue Medication: Loratadine tablets
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,482 participants
Where: No sites listed yet
Study dates: Jan 2013to Apr 2015
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

History of AR/ARC to house dust of 1 year duration or more (with or without asthma)
If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study
Able to read, understand and complete questionnaires and diaries

Who cannot join

Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen
History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed
Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis)
Received an immunosuppressive treatment within 3 months prior to screening
Unstable or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists [SABAs]) at any time within 3 months prior to screening
Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening

Show all 19Show fewer

History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen
History of chronic urticaria and/or angioedema within 2 years prior to screening
History of chronic sinusitis during 2 years prior to screening
Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study
Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening
Previous exposure to MK-8237
Receiving ongoing treatment with any specific immunotherapy at screening
Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine
Unable to meet medication washout requirements prior to screening
Unable or unwilling to comply with the use of self-injectable epinephrine
Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study
Likely to travel for extended periods of time during the efficacy assessment period
Participating in a different investigational study at any site during this study

About this study

Official title: A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)

The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).

Conditions: Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Nonseasonal
Being tested: MK-8237 tablets, Placebo tablets, Rescue Medication: Self-Injectable Epinephrine, Rescue Medication: Loratadine tablets, Rescue Medication: Olopatadine ophthalmic drops
Medical subject headings: Rhinitis, Allergic, Perennial

What participants receive

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

MK-8237 tabletsBiological
Also called SCH 900237
MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
Placebo tabletsBiological
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Rescue Medication: Self-Injectable EpinephrineDrug
Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
Rescue Medication: Loratadine tabletsDrug
Loratadine tablet 10 mg administered orally as needed for rescue medication.
Rescue Medication: Olopatadine ophthalmic dropsDrug
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
Rescue Medication: Mometasone furoate nasal sprayDrug
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.

Study groups in NCT01700192
Study group	Role	What they receive
MK-8237	Experimental	MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.). Receives: Biological: MK-8237 tablets; Drug: Rescue Medication: Self-Injectable Epinephrine; Drug: Rescue Medication: Loratadine tablets; Drug: Rescue Medication: Olopatadine ophthalmic drops; Drug: Rescue Medication: Mometasone furoate nasal spray
Placebo	Placebo comparator	Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. Receives: Biological: Placebo tablets; Drug: Rescue Medication: Self-Injectable Epinephrine; Drug: Rescue Medication: Loratadine tablets; Drug: Rescue Medication: Olopatadine ophthalmic drops; Drug: Rescue Medication: Mometasone furoate nasal spray

What is being measured

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

Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Measured: Last 8 weeks of treatment (Weeks 44 to 52)
Number of Participants Who Experience At Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 54 weeks
Number of Participants Who Discontinue Study Drug Due to an AE
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 52 weeks

Secondary outcomes (4)

Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Measured: Last 8 weeks of treatment (Weeks 44 to 52)
Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Measured: Last 8 weeks of treatment (Weeks 44 to 52)
Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Measured: Last 8 weeks of treatment (Weeks 44 to 52)
Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).
Measured: Last 8 weeks of treatment (Weeks 44 to 52)

Timeline

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

Jan 2013Apr 2015

First posted4 Oct 2012 (estimated)
Study startJan 2013
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
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
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,482 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01700192
Sponsor's protocol ID: P05607
Other IDs: MK-8237-001
Status last verified: Sep 2017
First submitted: 2 Oct 2012
Last updated: 15 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016 Dec;138(6):1631-1638. doi: 10.1016/j.jaci.2016.06.044. Epub 2016 Aug 10.
PubMed 27521719
Horn A, Bernstein DI, Okubo K, Dalgaard T, Hels O, Sorensen HF, Henriksen M, Azuma R, Mikler J, Nolte H. House dust mite sublingual immunotherapy tablet safety in adolescents with allergic rhinoconjunctivitis: Worldwide clinical trial results. Ann Allergy Asthma Immunol. 2023 Jun;130(6):797-804.e2. doi: 10.1016/j.anai.2023.03.006. Epub 2023 Mar 15.
PubMed 36924936
Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
PubMed 32926419
Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
PubMed 29656145
Nolte H, Bernstein DI, Sussman GL, Svanholm Fogh B, Lu S, Husoy B, Nelson HS. Impact of Adverse Event Solicitation on the Safety Profile of SQ House Dust Mite Sublingual Immunotherapy Tablet. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):2081-2086.e1. doi: 10.1016/j.jaip.2018.01.037. Epub 2018 Feb 10.
PubMed 29432959

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

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
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Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic

All Rhinitis, Allergic, Perennial trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)
ClinicalTrials.gov ID: NCT01700192
Acronym / sponsor ID: P05607
Conditions: Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Nonseasonal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,482 participants (actual)
Lead sponsor: ALK-Abelló A/SIndustry (pharma, biotech, devices)
Collaborators: Merck Sharp & Dohme LLC
Study start: Jan 2013
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 4 Oct 2012 (estimated)
Results: Posted 3 Mar 2017

Clinical summary

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

The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
MK-8237	Experimental	Biological: MK-8237 tablets, Drug: Rescue Medication: Self-Injectable Epinephrine, Drug: Rescue Medication: Loratadine tablets, Drug: Rescue Medication: Olopatadine ophthalmic drops, Drug: Rescue Medication: Mometasone furoate nasal sprayMK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).
Placebo	Placebo comparator	Biological: Placebo tablets, Drug: Rescue Medication: Self-Injectable Epinephrine, Drug: Rescue Medication: Loratadine tablets, Drug: Rescue Medication: Olopatadine ophthalmic drops, Drug: Rescue Medication: Mometasone furoate nasal sprayPlacebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.

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)

History of AR/ARC to house dust of 1 year duration or more (with or without asthma)
If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study
Able to read, understand and complete questionnaires and diaries

Key exclusion criteria (19 listed)

Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen
History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed
Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis)
Received an immunosuppressive treatment within 3 months prior to screening
Unstable or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists [SABAs]) at any time within 3 months prior to screening

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
MK-8237 tabletsAlso: SCH 900237MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.	Biological	MK-8237
Placebo tabletsPlacebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.	Biological	Placebo
Rescue Medication: Self-Injectable EpinephrineSelf-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.	Drug	MK-8237, Placebo
Rescue Medication: Loratadine tabletsLoratadine tablet 10 mg administered orally as needed for rescue medication.	Drug	MK-8237, Placebo
Rescue Medication: Olopatadine ophthalmic dropsOlopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.	Drug	MK-8237, Placebo
Rescue Medication: Mometasone furoate nasal sprayMometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.	Drug	MK-8237, Placebo

Primary outcome

Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Number of Participants Who Experience At Least One Adverse Event (AE)
Time frame: Up to 54 weeks
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants Who Discontinue Study Drug Due to an AE
Time frame: Up to 52 weeks
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

4 secondary outcomes

Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)

Results and safety

Results posted to the registry on 3 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-8237	741	561
Placebo	741	613

Primary outcome: Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment

Time frame: Last 8 weeks of treatment (Weeks 44 to 52). Mean (Standard Deviation). Unit: Score on a Scale

Measure	MK-8237 n = 566	Placebo n = 620
Value	4.67 (3.55)	5.49 (3.82)

MK-8237 vs Placebo: Median Difference (Final Values): -0.80 (95% CI -1.20 to -0.40), p <0.001, Wilcoxon (Mann-Whitney)
MK-8237 vs Placebo: Treatment Difference Relative to Placebo: -17.2 (95% CI -25.0 to -9.7)

Population analysed: The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.

Primary outcome: Number of Participants Who Experience At Least One Adverse Event (AE)

Time frame: Up to 54 weeks. Number. Unit: Participants

Measure	MK-8237 n = 743	Placebo n = 738
Value	676	539

Population analysed: The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).

Primary outcome: Number of Participants Who Discontinue Study Drug Due to an AE

Time frame: Up to 52 weeks. Number. Unit: Participants

Measure	MK-8237 n = 743	Placebo n = 738
Value	73	19

Population analysed: The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 54 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-8237 12 DU	11 of 743 (1.5%)	642 of 743 (86.4%)	Not reported
Placebo	7 of 738 (0.9%)	389 of 738 (52.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27521719Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016 Dec;138(6):1631-1638. doi: 10.1016/j.jaci.2016.06.044. Epub 2016 Aug 10.
Derived from this study: PubMed 36924936Horn A, Bernstein DI, Okubo K, Dalgaard T, Hels O, Sorensen HF, Henriksen M, Azuma R, Mikler J, Nolte H. House dust mite sublingual immunotherapy tablet safety in adolescents with allergic rhinoconjunctivitis: Worldwide clinical trial results. Ann Allergy Asthma Immunol. 2023 Jun;130(6):797-804.e2. doi: 10.1016/j.anai.2023.03.006. Epub 2023 Mar 15.
Derived from this study: PubMed 32926419Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
Derived from this study: PubMed 29656145Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
Derived from this study: PubMed 29432959Nolte H, Bernstein DI, Sussman GL, Svanholm Fogh B, Lu S, Husoy B, Nelson HS. Impact of Adverse Event Solicitation on the Safety Profile of SQ House Dust Mite Sublingual Immunotherapy Tablet. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):2081-2086.e1. doi: 10.1016/j.jaip.2018.01.037. Epub 2018 Feb 10.

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

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 19 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 15 Sep 2017. 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 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 3 Mar 2017). 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?

Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment (time frame: Last 8 weeks of treatment (Weeks 44 to 52)). The study lists 3 primary outcomes in all. 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 NCT01700192, which also lists 5 linked publications.

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 15 Sep 2017.