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NCT Number: NCT06668506

To Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis

This study aims to evaluate the improvement effect on subjective symptoms of gastritis and adverse events through patient self-assessment results (PRO) by conducting follow-up observations for patients with gastritis at 2 to 4 weeks after administration of Mucotra® SR tablets.

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Key information

Conditions

Gastritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Stomach Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Song Kwang Seon Internal medicine clinic

Wŏnju, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women aged ≥ 19 years
  • Subjects with acute or chronic gastritis, requiring treatment with Mucotra® SR tab
  • Subjects with subjective symptoms
  • Subjects who voluntarily consent to participate in this observational study

Exclusion criteria

  • Subjects who have had a hypersensitivity reaction to the components of Mucotra® SR tab
  • Subject with genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Treatment and study plan

Primary outcomes

  1. Change in total subjective symptom score compared to baseline

    Time frame: 2 weeks (up to 4 weeks)

    Change in total subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms.

Secondary outcomes

  1. Change in individual subjective symptom score compared to baseline

    Time frame: 2 weeks (maximum 4 weeks)

    Change in individual subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms.

  2. The effective rate of subjective symptoms compared to baseline

    Time frame: 2 weeks (maximum 4 weeks)

    The effective rate of subjective symptoms compared to baseline at 2 weeks (maximum 4 weeks). The effective rate is the percentage of patients whose total subjective symptom scores are reduced by more than 50% compared to their scores before administration.

  3. Overall change assessed by study subjects after administration of the study drug

    Time frame: 2 weeks (maximum 4 weeks)

    Overall change assessed by study subjects after administration of the study drug at 2 weeks. (maximum 4 weeks) The overall change is assessed using five criteria: very much improved, much improved, minimally improved, no change, and worse.

  4. Overall change assessed by the researcher after administration of the drug under study

    Time frame: 2 weeks (maximum 4 weeks)

    Overall change assessed by the researcher after administration of the drug under study at 2 weeks (maximum 4 weeks). The overall change is assessed using five criteria: very much improved, much improved, minimally improved, no change, and worse.

  5. Adverse events that occurred after administration of Mucotra® extended-release tablets

    Time frame: 2 weeks (maximum 4 weeks)

    Adverse events that occurred after administration of Mucotra® extended-release tablets at 2 weeks (maximum 4 weeks)

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Multi-center, Prospective, Observational Study to Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Oct 31, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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