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Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population

Primary Purpose

NSAIDs-associated Intestinal Mucosal Injury

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Irsogladine Maleate
Hydrotalcite
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSAIDs-associated Intestinal Mucosal Injury focused on measuring NSAIDs, intestinal mucosal injury

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Within 4 weeks before the study, NSAIDs were taken at least once a day with symptoms and signs of abdominal discomfort, such as abdominal pain, abdominal distension and dyspepsia;
  2. During the 8-week observation period of the study, NSAIDs will continue to be used in the same protocol (whether to stop NSAIDs during the study remains to be determined);
  3. Patients taking antisecretory drugs such as proton pump inhibitors or H2 receptor antagonists and gastric mucosal protectors such as rebapide or tiprexone were eligible;
  4. Willing to sign informed consent

Exclusion Criteria:

  1. Active gastrointestinal bleeding;
  2. Taking more than two NSAIDs, anticoagulants, steroid hormones or prostaglandin derivatives;
  3. Have a history of gastrointestinal surgery except appendectomy;
  4. Suspected small bowel obstruction;
  5. gastroduodenal ulcer;
  6. Severe cardiopulmonary diseases (NYHA grade IV cardiac function or respiratory failure);
  7. Significant renal impairment (serum creatinine ≥2 mg/dL or glomerular filtration rate GFR<40 mL/min);
  8. Liver insufficiency (liver function: total bilirubin >ULN, ASpartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≥ 2.0 × ULN);
  9. Confirmed or suspected combined with malignant tumor;
  10. pregnant and lactation women or women who do not exclude the possibility of pregnancy;
  11. Drug addicts or alcoholics;
  12. Participants in other drug trials within 3 months;
  13. The researcher considers it unsuitable for participants

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Irsogladine Maleate

    Hydrotalcite

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of small intestinal mucosal lesions under capsule endoscopy
    After 8 weeks of treatment, capsule endoscopy was repeated, and the number of small intestinal mucosal lesions under the microscope decreased by ≥1 or the Lewis score decreased by more than before, which was considered effective.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2022
    Last Updated
    March 23, 2022
    Sponsor
    Lee's Pharmaceutical Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05249725
    Brief Title
    Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population
    Official Title
    Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    August 2022 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lee's Pharmaceutical Limited

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    All patients who met the inclusion criteria and agreed to participate in the study underwent baseline capsule endoscopy. Patients with intestinal mucosal injury detected during the initial capsule endoscopy were randomly divided into isoladin maleate group or magnesium aluminum carbonate control group using computer-generated random numbers. Patients in the isoladine maleate group received 4 mg isoladine maleate (Gesellon, Japan) every morning for 4 weeks (or 8 weeks, duration to be determined); Magnesium aluminum carbonate control group received 1 g magnesium aluminum carbonate every morning, afternoon and evening for 4 weeks (or 8 weeks, course to be determined). After treatment, capsule endoscopy was performed again to evaluate the healing of intestinal mucosa.
    Detailed Description
    In this prospective randomized controlled study, 100 patients with NSAIDS-related intestinal mucosal injury will be enrolled in 10 clinical centers across China from July 2021 to December 2022. All patients who met the inclusion criteria and agreed to participate in the study underwent baseline capsule endoscopy. Patients with intestinal mucosal injury detected during the initial capsule endoscopy were randomly divided into isoladin maleate group or magnesium aluminum carbonate control group using computer-generated random numbers. Patients in the isoladine maleate group received 4 mg isoladine maleate (Gesellon, Japan) every morning for 4 weeks (or 8 weeks, duration to be determined); Magnesium aluminum carbonate control group received 1 g magnesium aluminum carbonate every morning, afternoon and evening for 4 weeks (or 8 weeks, course to be determined). After treatment, capsule endoscopy was performed again to evaluate the healing of intestinal mucosa. Laboratory tests including blood routine, stool routine, and occult blood were performed at the beginning and end of the study. Abdominal symptoms and signs were assessed by two experienced clinicians at week 0, 1, 2, and 4 (8) of the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NSAIDs-associated Intestinal Mucosal Injury
    Keywords
    NSAIDs, intestinal mucosal injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Irsogladine Maleate
    Arm Type
    Experimental
    Arm Title
    Hydrotalcite
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Irsogladine Maleate
    Intervention Description
    Orally administration of irsogladine maleate 4mg/day, for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrotalcite
    Intervention Description
    Patients were given 1 g hydrotalcite every morning, afternoon and evening for 8 weeks.
    Primary Outcome Measure Information:
    Title
    Number of small intestinal mucosal lesions under capsule endoscopy
    Description
    After 8 weeks of treatment, capsule endoscopy was repeated, and the number of small intestinal mucosal lesions under the microscope decreased by ≥1 or the Lewis score decreased by more than before, which was considered effective.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Within 4 weeks before the study, NSAIDs were taken at least once a day with symptoms and signs of abdominal discomfort, such as abdominal pain, abdominal distension and dyspepsia; During the 8-week observation period of the study, NSAIDs will continue to be used in the same protocol (whether to stop NSAIDs during the study remains to be determined); Patients taking antisecretory drugs such as proton pump inhibitors or H2 receptor antagonists and gastric mucosal protectors such as rebapide or tiprexone were eligible; Willing to sign informed consent Exclusion Criteria: Active gastrointestinal bleeding; Taking more than two NSAIDs, anticoagulants, steroid hormones or prostaglandin derivatives; Have a history of gastrointestinal surgery except appendectomy; Suspected small bowel obstruction; gastroduodenal ulcer; Severe cardiopulmonary diseases (NYHA grade IV cardiac function or respiratory failure); Significant renal impairment (serum creatinine ≥2 mg/dL or glomerular filtration rate GFR<40 mL/min); Liver insufficiency (liver function: total bilirubin >ULN, ASpartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≥ 2.0 × ULN); Confirmed or suspected combined with malignant tumor; pregnant and lactation women or women who do not exclude the possibility of pregnancy; Drug addicts or alcoholics; Participants in other drug trials within 3 months; The researcher considers it unsuitable for participants
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    HAN SHIJI
    Phone
    13929517813
    Email
    shiji.han@leespharm.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population

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