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KRP-DC125 Pivotal Study

KRP-DC125 Pivotal Study - A Multicenter, randomized, single-blind, parallel-group comparative study of KRP-DC125 in patients with chronic cough -

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2012260017
Enrollment
160
Registered
2026-06-09
Start date
2026-06-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic cough

Interventions

Treatment group: The treatment group app is administered in addition to Standard of care. Control group: The control group app is administered in addition to Standard of care.

Sponsors

Yashiro Kenichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Men or women aged at least 18 years and younger than 75 years (2)At Visit 1, the patient had a cough that had persisted for at least 8 weeks, and despite treatment in accordance with clinical practice guidelines, Investigators designated physician determined that medical intervention was necessary for the cough. (3)Based on the results of a chest X-ray or chest CT scan taken within the past two years prior to this visit and after the onset of the current cough episode (including a series of cough symptoms prior to the diagnosis of chronic cough), the patient has been determined not to have any abnormalities or serious lung diseases that are considered to be significantly affecting the current cough. (4)Regarding the current cough episode, the patient does not produce a clinically significant amount of sputum (generally more than approximately 2 tablespoons per day) on a daily basis.

Exclusion criteria

Exclusion criteria: (1)Currently smokes, quit smoking within the 6 months prior to Visit 1, or has a history of smoking exceeding 20 pack-years ((number of cigarettes smoked per day / 20) * number of years smoked). (2)Has accompanying vocal cord polyps or nodules. (3)The principal investigator or other designated personnel determined that the current cough episode is caused by a dysphagia-related cough, or that there is a strong suspicion that it is. (4)Patients with concurrent or a history of malignant tumors of the pharynx, larynx, or tongue; or patients with a history of malignant tumors other than those of the pharynx, larynx, or tongue within 5 years prior to Visit 1.

Design outcomes

Primary

MeasureTime frame
Cough frequency (average number of coughs per hour)

Contacts

Public ContactKenichi Yashiro

KYORIN Pharmaceutical Co.,Ltd.

ml-kyorin_jrct@mb.kyorin-pharm.co.jp+81-3-6368-4834

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026