Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

NCT02320396 | Completed Phase 3 Results

• 3 other identifiers: 4117-204152861MK-4117-204
• Study Type: interventional
• Target: 449
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy

  The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), rhinorrhea (daily frequency of blowing nose scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), nasal congestion (scored from 0 \[no nasal blockage\] to 4 \[completely obstructed all day\]), and nasal itching (scored from 0 \[none\] to 4 \[nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement - BL measurement.

  Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment

• Number of Participants Who Experience at Least One Adverse Event (AE)

  An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.

  Up to 4 weeks (Up to 2 weeks after last dose of study drug)

• Number of Participants Who Discontinue Study Drug Due to an AE

  An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.

  Up to 2 weeks

Secondary Outcomes (10)

• Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment

  Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment

• Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)

  Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment

• Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)

  Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment

• Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy

  Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)

• Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)

  Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment

Study Arms (2)

Desloratadine

EXPERIMENTAL

After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period.

Drug: Desloratadine 5 mg

Placebo

PLACEBO COMPARATOR

After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.

Drug: Placebo

Interventions

Desloratadine 5 mg DRUG

Desloratadine 5 mg tablets

Desloratadine

Placebo DRUG

Placebo tablets

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms
• Male or female who is unlikely to conceive: a surgically sterilized female, female who has reached natural menopause, or is of reproductive potential and agrees to either remain abstinent or use (or have her partner use) 2 acceptable methods of birth control from study start through 14 days after the last dose of study drug.

You may not qualify if:

• Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment
• Has a coexisting infection or systemic mycosis for which there are no effective antibiotics
• Has asthma that is under treatment and/or uncontrolled
• Has nasal septum ulcers, nasal surgery, or nasal trauma which have not healed
• Has vasomotor rhinitis or eosinophilic rhinitis
• Has a history of hypersensitivity to antihistamines or ingredients of study drug
• Has had treatment with corticosteroids (oral, injectable, suppository, depot drugs \[injectable\]) or immunological drugs within 28 days prior to Visit 2
• Is currently receiving treatment with another investigational drug or has received an investigational drug within prior 3 months
• Has started specific desensitization therapy (allergen immunotherapy) or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who has received such therapies within prior 3 months
• Has received coagulation or resection using laser therapy etc. for treatment for nasal symptoms
• Will receive nasal nebulizer therapy and/or thermotherapy during study period
• Has severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
• Has a history of malignancy or clinically important hematological disorder, except for adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
• Has a history of severe drug allergy (e.g. anaphylactoid reaction)
• Is pregnant or lactating or may be pregnant

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Okubo K, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with seasonal allergic rhinitis: A randomized controlled trial. Arerugi. 2016;32(11):863-876.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11

  RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 19, 2014
• Study Start: January 9, 2015
• Primary Completion: April 27, 2015
• Study Completion: April 27, 2015
• Last Updated: May 17, 2024
• Results First Posted: May 30, 2016

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share