BridgeMD
New treatment option for Reflux Esophagitis (RE)
Official title A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.
ClinicalTrials.gov ID: NCT07010107
What this study is testing
- What it's testing
- This Phase III clinical trial is designed to assess the efficacy and safety of Anaprazole 60 mg once daily (QD) administered over a period of up to 8 weeks, compared with Rabeprazole 20 mg QD, in patients with reflux esophagitis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The patients provided voluntary signed informed consent forms.
- Aged ≥18 years and ≤75 years old.
- Endoscopically diagnosed as reflux esophagitis (LA grade B-D) within 14 days before randomization.
You likely can't join if
- Researchers believe that patients with uncontrolled primary diseases are not suitable for clinical trials, particularly those with a history of...
- Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the how well it works...
- Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries.
- Patients confirmed to have active peptic ulcers or active upper/lower gastrointestinal bleeding within the last 30 days via...
- Patients with a history of Zollinger-Ellison syndrome, achalasia of the cardia, secondary esophageal motility disorders, irritable bowel syndrome...
- Patients with a history of malignant tumor or having received treatment for malignant tumor within 5 years prior to randomization.
See the full eligibility criteria
- The patients provided voluntary signed informed consent forms.
- Aged ≥18 years and ≤75 years old.
- Endoscopically diagnosed as reflux esophagitis (LA grade B-D) within 14 days before randomization.
- Researchers believe that patients with uncontrolled primary diseases are not suitable for clinical trials, particularly those with a history of severe conditions affecting the cardiovascular, nervous, respiratory...
- Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the how well it works evaluation.
- Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries.
- Patients confirmed to have active peptic ulcers or active upper/lower gastrointestinal bleeding within the last 30 days via esophagogastroduodenoscopy (EGD).
- Patients with a history of Zollinger-Ellison syndrome, achalasia of the cardia, secondary esophageal motility disorders, irritable bowel syndrome, inflammatory bowel disease, or other gastrointestinal functional...
- Patients with a history of malignant tumor or having received treatment for malignant tumor within 5 years prior to randomization.
- Patients with a history of mental illness or a history of drug or alcohol abuse within 12 months prior to screening.
- Patients who tested positive for HIV, HBsAg, and/or HCV antibodies during screening.
- Patients with malignant tumors or a predisposition to malignancy in the stomach or esophagus.
- Patients with abnormal liver function: AST and/or ALT levels ≥2.0×ULN, and/or total bilirubin (TBIL) levels ≥1.5×ULN.
- Patients with abnormal renal function: Serum creatinine levels ≥1.5×ULN, blood urea or blood urea nitrogen levels ≥1.5×ULN.
- Patients with clinically significant ECG abnormalities, including QTc interval prolongation (QTcF ≥450 ms for men and QTcF ≥470 ms for women).
- Patients with poorly controlled diabetes or hypertension.
- Patients who were unable to undergo esophagogastroduodenoscopy (EGD).
- Patients with a known allergy to the components or ingredients of Anaprazole or Rabeprazole.
- Patients who had used proton pump inhibitors at therapeutic doses within 14 days prior to randomization.
- Patients who had used therapeutic doses of other drugs for treating acid reflux within 7 days prior to randomization.
- Patients required to continue receiving non-steroidal anti-inflammatory drugs (NSAIDs), systemic glucocorticoids, or clopidogrel during the trial period.
- Patients whose assessment may be affected by alcohol, drug, or medication withdrawal during the study.
- Pregnant or lactating women, as well as patients planning to conceive within 30 days before randomization and up to 6 months following the trial completion.
- Patients who had participated in other drug clinical trials within 3 months prior to randomization.
- Patients with other conditions deemed by the researchers as unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.