A Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. in Patients With Erosive Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660122
• Other study ID #: DWFE_P405
• Status: Recruiting
• Start date: November 11, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: HyeongSeon Noh
• Phone: 8210-4266-0549
• Email: hsno116[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.

Description:

This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.

Subjects who met the inclusion/exclusion criteria will administer Fexuclue Tablet once a day for four weeks after registration, regardless of their meals. If esophagitis is not treated or symptoms continue after 4 weeks of administration, the subject will continue to administer Fexuclue Tablet for 4 more weeks (maximum administration period: 8 weeks).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 31, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Adult men and women aged 19 to 75 years of age at the time of registration.

2. A patient with erosive gastroesophageal reflux disease who is scheduled to administer Fexuclue Tab. for the first time based on the medical judgement of the researcher based on the medication authorization.

3. A person who voluntarily agrees to participate in this observation study and signed the informed consent form.

Exclusion Criteria:

1. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet

• Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof

• Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations

• Pregnant and lactating women

• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion

2. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;

3. In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Fexuprazan Hydrochloride
Fexuclue Tablet 40mg

Locations

Country	Name	City	State
Korea, Republic of	Kosin University Gospel Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average score change	in Reflux Disease Questionnaire	at 4 weeks (up to 8 weeks)
Secondary	Average score change	individual score in Reflux Disease Questionnaire	at 4 weeks (up to 8 weeks)