Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"

NCT03214952 | Completed Results

• 2 other identifiers: Vonoprazan-5001JapicCTI-163177
• Study Type: observational
• Target: 3,183
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.

Conditions

Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions

  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug.

  Up to 8 weeks

• Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug.

  Up to 6 weeks

• Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug.

  Up to 8 weeks

Secondary Outcomes (6)

• Endoscopic Cure Rate in Participants With Gastric Ulcer

  Up to 8 weeks

• Endoscopic Cure Rate in Participants With Duodenal Ulcer

  Up to 6 weeks

• Endoscopic Cure Rate in Participants With Reflux Esophagitis

  Up to 8 weeks

• Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved

  Baseline and at the end of the survey (up to 8 weeks)

• Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved

  Baseline and at the end of the survey (up to 6 weeks)

Study Arms (1)

Vonoprazan 20 mg

The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.

Drug: Vonoprazan

Interventions

Vonoprazan DRUG

Vonoprazan tablets

Also known as: Takecab tablets, TAK-438

Vonoprazan 20 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of participants with a diagnosis of gastric ulcer, duodenal ulcer, and reflux esophagitis and receive Vonoprazan in the routine clinical setting.

You may qualify if:

• \- Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis

You may not qualify if:

• Participants with previous history of hypersensitivity to ingredients in Takecab tablets
• Participants taking atazanavir sulfate or rilpivirine hydrochloride
• Participants meeting the criteria of scarring stage (S1, S2) of endoscopic classification defined by Sakita and Miwa at the start of the treatment with Takecab tablets, in the case that the target disease is gastric ulcer or duodenal ulcer
• Participants meeting the criteria of Grade N or Grade M of Los Angeles classification (Hoshihara's modification) at the start of the treatment with Takecab tablets, in the case that the target disease is reflux esophagitis.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

MeSH Terms

Conditions

Stomach Ulcer; Duodenal Ulcer; Esophagitis, Peptic

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Esophagitis; Esophageal Diseases; Gastroenteritis

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: July 12, 2017
• Study Start: March 1, 2016
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: December 12, 2019
• Results First Posted: December 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)