Clinical Trial: DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers

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 Summary:

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.


Sponsor: Dexa Medica Group

Current Primary Outcome: Endoscopic ulcer healing rate [ Time Frame: 8 weeks ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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

    The improvement rate of each of gastric symptoms at each of the follow-up visits (after 4 and 8 weeks of treatment):

    • abdominal or epigastric pain (middle or upper stomach)
    • nausea or vomiting,
    • bloating
  • The quality of ulcer healing [ Time Frame: 8 weeks ]
    The quality of ulcer healing as measured by the levels of gastric mucosal bFGF (basic fibroblast growth factor) and COX-2 (cyclo-oxygenase), at baseline and Week 8 of treatment.
  • Patients' global evaluation for their symptoms [ Time Frame: 4 and 8 weeks ]
    Patients' global evaluation for their symptoms categorized as: no improvement or slightly improved or moderately improved or markedly improved, at Week 4 and 8 (end of study).
  • Liver function [ Time Frame: 8 weeks ]
    Liver function (serum ALT (alanine-aminotransferase), serum AST (aspartate-aminotransferase), alkaline phosphatase, total bilirubin) at baseline and at the end of study
  • Renal function [ Time Frame: 8 weeks ]
    Renal function (serum creatinine and BUN (blood urea nitrogen) level) at baseline and at the end of study
  • Adverse events [ Time Frame: 4 and 8 weeks ]
    Adverse event, will be observed throughout the study conduct


Original Secondary Outcome:

  • Endoscopic ulcer improvement rate [ Time Frame: 4 and 8 weeks ]
    Endoscopic ulcer improvement rate at each of the follow-up visits (after 4 and 8 weeks of treatment). Ulcer improvement rate is defined as the proportion of subjects with either complete (referring to S1 or S2 Scarring stage according to Sakita-Fukutomi classification) or partially healed ulcers (referring to Active (A1-A2) or Healing (H1-H2) stage) as confirmed by endoscopic finding.
  • The improvement rate of each of gastric symptoms [ Time Frame: 4 and 8 weeks ]

    The improvement rate of each of gastric symptoms at each of the follow-up visits (after 4 and 8 weeks of treatment):

    • abdominal or epigastric pain (middle or upper stomach)
    • nausea or vomiting,
    • bloating Improvement rate is defined as the proportion of subjects who undergo improvement (score reduction) of each of the symptoms.

    The severity of each symptom is categorized by a 4-point scale as follows:

    0 = None = no symptoms

    1. = Mild = mild discomfort, symptoms are present occasionally, but easily tolerated
    2. = Moderate = moderate discomfort, symptoms are present most of the time, causing interference with normal daily activities
    3. = Severe = severe discomfort, symptoms are present continuously, incapacitating symptoms preventing performance of normal daily activities
  • The quality of ulcer healing [ Time Frame: 8 weeks ]
    The quality of ulcer healing as measured by the levels of gastric mucosal bFGF (basic fibroblast growth factor) and COX-2, at baseline and Week 8 of treatment.
  • The thickness of gastric mucus [ Time Frame: 8 weeks ]
    Gastric mucus' thickness will be measured quantitatively at baseline and end (Week 8) of treatment.
  • Patients' global evaluation for their symptoms [ Time Frame: 4 and 8 weeks ]
    Patients' global evaluation for their symptoms categorized as: no improvement or slightly improved or moderately improved or markedly improved, at Week 4 and 8 (end of study).
  • Vital signs [ Time Frame: 4 and 8 weeks ]
    Vital signs (blood pressure, heart rate, respiration rate) from baseline to every follow-up visit including end of study
  • Electrocardiography (ECG) [ Time Frame: 8 weeks ]
    Electrocardiography (ECG) at baseline and at the end of study
  • Liver function [ Time Frame: 8 weeks ]
    Liver function (serum ALT, serum AST, alkaline phosphatase, total bilirubin) at baseline and at the end of study
  • Renal function [ Time Frame: 8 weeks ]
    Renal function (serum creatinine and BUN level) at baseline and at the end of study
  • Adverse events [ Time Frame: 4 and 8 weeks ]
    Adverse event, will be observed throughout the study conduct


Information By: Dexa Medica Group

Dates:
Date Received: October 7, 2014
Date Started: October 2014
Date Completion: March 2018
Last Updated: May 2, 2017
Last Verified: May 2017