A research study for subjects with clinically significant heartburn

  • STATUS
    Recruiting
Updated on 23 November 2020
lansoprazole
esophagitis

Summary

This study will assess the efficacy and safety of study drug, vonoprazan (20 mg once daily [QD]) compared to lansoprazole (30 mg QD) in the healing and relief of heartburn in subjects with endoscopically proven Erosive Esophagitis (EE).

 

Description

Study Duration: Following an initial Screening period (of up to 35 days), subjects will be randomized to receive either study medication - vonoprazan 20 mg or lansoprazole 30 mg - for up to 8 weeks. For subjects showing endoscopic healing at week 2 of treatment or week 8 of treatment, they may enter the maintenance phase of the study to continue for 24 weeks. Subjects that do not show endoscopic improvement by week 8 will be discontinued from the study. Subjects will have a safety follow-up visit planned 4 weeks after the last dose of study drug. The total duration of the study is up to 41 weeks.Study Medication/Investigational Product: Eligible study participants will be randomly assigned treatment of vonoprazan 20 mg daily or lansoprazole 30 mg daily in the initial 8 week healing phase. In the maintenance phase, blinded study drug (vonoprazan 10 mg QD, vonoprazan 20 mg QD, or lansoprazole 15 mg QD) will be taken orally for 24 weeks.Study Procedures/Safety Assessments: Physical Exams with the study doctors, vital signs, laboratory test values (hematology, serum chemistry, urinalysis); serum gastrin and pepsinogen I/II levels, gastric biopsy, electrocardiogram (for Maintenance Phase only), twice daily symptom entry in an electronic diary.Stipend: A stipend will be provided to qualified study participants to help defray time and travel costs. Stipends are paid on a periodic basis as specifically outlined in the subject information and consent form.Note: There is no stipend for a pre-study visit, if such a visit is scheduled.

Details
Condition Helicobacter pylori, Heartburn, Gastroesophageal Reflux Disease (GERD), Heartburn (Pediatric)
Clinical Study IdentifierTX237537
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Be male or female ≥ 18 years of age
If a male or female of reproductive age/childbearing potential
Be willing to use contraception (birth control) throughout study participation
Not planning pregnancy
Not a currently pregnant or currently lactating female
Have a diagnosis of erosive esophagitis (EE) of LA classification Grades A to D confirmed endoscopically during the screening period

Exclusion Criteria

The subject is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization
The subject has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus OR any other condition affecting the esophagus
An active gastric or duodenal ulcer at the start of the screening period
The subject has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period
_The subject may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ._
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note