DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02262169
• Date of registration: 07/10/2014
• Prospective Registration: No
• Primary sponsor: Dexa Medica Group
• Public title: DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
• Scientific title: DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
• Date of first enrolment: October 2014
• Target sample size: 32
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02262169
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Indonesia

Contacts

• Name: IDN Wibawa Prof. DR. Dr., SpPD-KGEH
• Affiliation: Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects aged 18-75 years old.

- Diagnosed as non-bleeding peptic ulcers who do not require endoscopic therapy, as
confirmed by :

- The presence of endoscopically confirmed gastric or duodenal ulcer(s) at size(s)
of at least 3 mm or larger.

- Subjects with low-risk of recurrent bleeding, defined as both:

- Complete Rockall score of = 7.

- Endoscopic stigmata (lesion) of grade II-C or III based on Forrest
classification.

- Able to take oral medication.

Exclusion Criteria:

- For females of childbearing potential: pregnancy, breast-feeding, the intention of
becoming pregnant during the study participation.

- Patients must accept pregnancy tests during the trial if menstrual cycle is
missed

- Fertile patients must use a reliable and effective contraceptive

- History of or known or suspected Zollinger Ellison syndrome.

- History of endoscopic therapy for bleeding ulcer within the past 4 weeks.

- Indication for endoscopic hemostasis therapy.

- Presence of Helicobacter pylori infection

- History of or known coronary artery disease (CAD), congestive heart failure, pulmonary
disease, and any other uncontrolled chronic diseases.

- History of or known gastrointestinal malignancy or ulcers associated to malignancy.

- Currently known being afflicted by serious infection(s).

- Inadequate liver function

- Inadequate renal function

- Subjects being under therapy with any herbal medicines.

- Known hypersensitivity or idiosyncratic reaction or adverse drug reactions to proton
pump inhibitors (PPIs).

- Participation in any other clinical studies within 30 days prior to screening.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non-Bleeding Peptic Ulcers

Intervention(s)

Drug: Omeprazole

Drug: DLBS2411

Drug: Placebo capsule of Omeprazole

Drug: Placebo caplet of DLBS2411

Primary Outcome(s)

Endoscopic ulcer healing rate [Time Frame: 8 weeks]

Secondary Outcome(s)

Patients' global evaluation for their symptoms [Time Frame: 4 and 8 weeks]

The quality of ulcer healing [Time Frame: 8 weeks]

Adverse events [Time Frame: 4 and 8 weeks]

Liver function [Time Frame: 8 weeks]

Renal function [Time Frame: 8 weeks]

Mucosal thickness [Time Frame: 8 weeks]

The improvement rate of each of gastric symptoms [Time Frame: 4 and 8 weeks]

Secondary ID(s)

DLBS2411-0313

Source(s) of Monetary Support

Please refer to primary and secondary sponsors