An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)

NCT ID: NCT01916967

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-27
• Study Completion Date: 2014-03-13

Brief Summary

This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.

Conditions

Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Desloratadine 5 mg

Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks

Group Type: EXPERIMENTAL

Desloratadine

Intervention Type: DRUG

Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks

Placebo

Intervention Type: DRUG

Placebo tablets, given orally, once daily in the evening for 2 weeks

Desloratadine 10 mg

Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks

Group Type: EXPERIMENTAL

Desloratadine

Intervention Type: DRUG

Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks

Placebo

Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets, given orally, once daily in the evening for 2 weeks

Interventions

Desloratadine

Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks

Intervention Type: DRUG

Placebo

Placebo tablets, given orally, once daily in the evening for 2 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chronic urticaria [rash (erythema, wheal) for more than 1 month without any known cause]
• Out-patient

Exclusion Criteria

• Stimulation-induced urticaria [physical urticaria (e.g. cold, solar, and heat urticaria), cholinergic urticaria, contact urticaria)]
• Hypersensitivity to antihistamines or ingredients of a study drug

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Hide M, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with chronic urticaria: A randomized controlled trial. J Clin Therapeut Med. 2016;32(11):891-903.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11

Reference Type: RESULT

Other Identifiers

132243

Identifier Type: REGISTRY

Identifier Source: secondary_id

4117-201

Identifier Type: -

Identifier Source: org_study_id