A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.

• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04503629
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 20.8

Study Details

Study Description

Brief Summary

A phase 2,double-blinded, double dummy, parallel, positive drug, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD, 40mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.

Condition or Disease	Intervention/Treatment	Phase
Duodenal Ulcer，DU	Drug: Anaprazole Sodium; Drug: Anaprazole Sodium; Drug: Rabeprazole sodium	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2,Double-blinded, Double Dummy, Positive Drug, Parallel, Randomised Controlled Multicenter Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
• Actual Study Start Date: Oct 9, 2018
• Actual Primary Completion Date: May 17, 2019
• Actual Study Completion Date: May 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anaprazole Sodium 20mg QD administered orally once every 30-60 minutes before breakfast for 4 weeks	Drug: Anaprazole Sodium; Anaprazole Sodium 20mg
Experimental: Anaprazole Sodium 40mg QD administered orally once every 30-60 minutes before breakfast for 4 weeks	Drug: Anaprazole Sodium; Anaprazole Sodium 40mg
Active Comparator: Rabeprazole sodium 10mg QD administered orally once every 30-60 minutes before breakfast for 4 weeks	Drug: Rabeprazole sodium; Rabeprazole sodium 10mg

Outcome Measures

Primary Outcome Measures

1. The endoscopic healing rate of duodenal ulcers at week 4. [Treatment of 4 weeks]

   The endoscopic ulcer healing rate is defined as the percentage of patients with endoscopic ulcer healed evaluated by investigators.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥18 years, male and female

2. Has endoscopic diagnosis of active duodenal ulcer(s) (A1 or A2 stage) within 7 days prior to randomization

3. 1 or 2 ulcers, 3-15 mm in diameter.

4. Signed informed concent form

Exclusion Criteria:

1. Has malignancy ulcer or malignancy ulcer not excluded, compouned ulcer, stress ulcer, esophageal erosion and ulcer, reflux esophagitis, Zollinger-Ellison syndrome.

2. Has esophageal and gastric varices；

3. With severe compliaction, such as pyloric obstruction, bleeding (Forrest I, IIa and IIb) or perforation, and etc；

4. Has other gastrointestinal disease (e.g.gastric ulcer), or has history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)；

5. Has undergone surgical resection or partly resection of esophageal, stomach or duodenum；

6. Has used Proton Pump Inhibitors(PPIs) within 5 days prior to randomization, or continuous more than 3 days of use of Proton Pump Inhibitors within 2 weeks prior to randomization；

7. Has been treated with triple or quandruple Helicobacter pylori eradication therapy included PPIs within 28 days prior to randomization；

8. Current use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) which may induce ulcer or ulceric bleeding or continuous more than 3 days of use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) within 28 days prior to randomization；

9. Laboratory tests performed in screning stage revealed Alanine aminotransferase (ALT) or aspartate aminotransferase (AST): > 1.5 upper limit of normal (ULN);

10. Laboratory tests performed in screning stage revealed thyroid stimulating hormone (TSH)；

11. Woman in pregnancy or lactation period；

12. Plan for pregancy or not willing to contracept with reliable contraception method during study period and within 90 days after the final time of investigational drug administratio；

13. Have alcohol abuse or drug abuse 1 years prior to screening；

14. Has hypersensitivity or allergy to investigatory drug, comparatory drug or related supplements；

15. Has participated or been participating other clinical trials(non-interventional study is excluded)；

16. Has an uncotroled disease, such as has a history of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, or mental or psychological disorders with drug treatment that,in the opinion of the investigator, would not be suitable for participating this clinical trial.

17. In the opinion of the investigator, the patients with other situation would not be suitable for participating this clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Fisrst Affiliated Hospital of NanChang University	Nanchang	Jiangxi	China	330006

Sponsors and Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sihuan Pharmaceutical Holdings Group Ltd.
• ClinicalTrials.gov Identifier: NCT04503629
• Other Study ID Numbers: 3571-DU-2001
• First Posted: Aug 7, 2020
• Last Update Posted: Aug 7, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Duodenal Ulcer; Ulcer; Rabeprazole

Study Results

No Results Posted as of Aug 7, 2020