DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers

NCT02262169 | Terminated Phase 3

• 1 other identifier: DLBS2411-0313
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2-arm, prospective, double-blind, double-dummy, randomized-controlled study using DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), or omeprazole at a dose of 40 mg once daily (before morning meal), for an 8-week course of therapy, for the treatment of patients with any non-bleeding peptic ulcers. DLBS2411 is a bioactive fraction of an Indonesian native herbal, Cinnamomum burmanii, locally known as kayu manis have been proven at cellular and genetic levels to have an antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing gastric acid secretion; while its gastro-protective defense mechanism works through the promotion of COX-2 derived prostaglandin (PgE2) synthesis, stimulating gastric-epithelial mucous and bicarbonate secretion; anti-oxidative activity; and endothelial-nitric oxide (NO) formation. Recent study of DLBS2411 in healthy volunteers demonstrated the effective role and safety of DLBS2411 in suppressing intragastric acidity. Having such mechanisms of action, DLBS2411 is hypothesized to benefit in peptic ulcers.

Conditions

Non-Bleeding Peptic Ulcers

Keywords

Non-Bleeding Peptic Ulcers, DLBS2411, Ulcer Healing

Outcome Measures

Primary Outcomes (1)

• Endoscopic ulcer healing rate

  Endoscopic ulcer healing rate after 8 weeks of treatment. Ulcer healing rate is defined as the proportion of subjects with complete ulcer-healing (referring to S1 or S2 Scarring stage according to Sakita-Fukutomi classification) as confirmed by endoscopic finding.

  8 weeks

Secondary Outcomes (7)

• The improvement rate of each of gastric symptoms

  4 and 8 weeks

• The quality of ulcer healing

  8 weeks

• Mucosal thickness

  8 weeks

• Patients' global evaluation for their symptoms

  4 and 8 weeks

• Liver function

  8 weeks

Study Arms (2)

Treatment I

ACTIVE COMPARATOR

2 Omeprazole capsules 20 mg once daily and 1 placebo caplet of DLBS2411, twice daily

Drug: Omeprazole; Drug: Placebo caplet of DLBS2411

Treatment II

EXPERIMENTAL

1 DLBS2411 caplet 250 mg twice daily and 2 placebo capsules of Omeprazole once daily

Drug: DLBS2411; Drug: Placebo capsule of Omeprazole

Interventions

Omeprazole DRUG

2 Omeprazole capsules 20 mg, once daily

Treatment I

Placebo caplet of DLBS2411 DRUG

1 placebo caplet of DLBS2411, twice daily

Also known as: Placebo caplet of Redacid

Treatment I

DLBS2411 DRUG

1 DLBS2411 caplet 250 mg, twice daily

Also known as: Redacid

Treatment II

Placebo capsule of Omeprazole DRUG

2 placebo capsules of Omeprazole, once daily

Treatment II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• IDN Wibawa Prof. DR. Dr., SpPD-KGEH

  Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

ID (1)