Clinical trial NCT02262169: DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
Official title: DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Bleeding Peptic Ulcers
Keywords: Non-Bleeding Peptic Ulcers, DLBS2411, Ulcer Healing
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A total of 140 subjects will be allocated into 2 groups of treatment; each group will consist of 70 subjects with the treatment regimens:

Treatment I : 2 capsules of Omeprazole 20 mg, once daily and 1 placebo caplet of DLBS2411, twice daily Treatment II : 1 caplet of DLBS2411 250 mg, twice daily and 2 placebo capsules of omeprazole, once daily

DLBS2411 will be administered twice daily at least 30 minutes before morning and evening meals, while omeprazole, once daily before morning meals, for 8 weeks of study period.

The eligible subjects will receive either study medication (Treatment 1 or Treatment 2), for 8 weeks of treatment; and will be instructed to come to the clinic every 4-week interval throughout the study period.

Subjects will be evaluated for treatment efficacy at baseline and at interval of 4 weeks over the 8-week course of therapy.

The safety profile of study medication other than vital signs and adverse event will be measured at baseline and end of study. Vital signs and adverse event will be measured at baseline and every follow-up visit including end of study.

Eligibility 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.

Primary outcomes:
measure: Endoscopic ulcer healing rate
timeFrame: 8 weeks
Secondary outcomes:
measure: The improvement rate of each of gastric symptoms
timeFrame: 4 and 8 weeks
measure: The quality of ulcer healing
timeFrame: 8 weeks
measure: Mucosal thickness
timeFrame: 8 weeks
measure: Patients' global evaluation for their symptoms
timeFrame: 4 and 8 weeks
measure: Liver function
timeFrame: 8 weeks
measure: Renal function
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital
state: Bali
Study officials:
affiliation: Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital
name: IDN Wibawa Prof. DR. Dr., SpPD-KGEH
role: PRINCIPAL_INVESTIGATOR
References: