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A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M

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ClinicalTrials.gov Identifier: NCT02493712
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
inVentiv Health Clinical
Information provided by (Responsible Party):
Holy Stone Healthcare Co., Ltd

Brief Summary:
IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the clinical efficacy of IBD98-M delayed release capsules (in a fixed combination) over a 6-week treatment period and 2 weeks follow up.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: High dose Drug: Low dose Drug: Placebo Phase 2

Detailed Description:

Study IBD98-M-2002 is a Phase 2a, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in patients with active, mild to moderate UC. It is being conducted as an exploratory proof of concept study to investigate the clinical efficacy of IBD98-M delayed-release capsules (in a fixed combination) over a 6-week treatment period and a 2-week follow-up period.

Patients will be screened for study enrollment up to 4 weeks prior to randomization (Visit 3). During the screening period, patients will be evaluated by conducting laboratory tests, physical examination, and sigmoidoscopy. To be eligible, patients are to have a score of ≥4 and ≤10 on the UCDAI, and a score of ≥1 on the UCDAI endoscopy subscore. In addition, the diagnosis of UC must be confirmed by endoscopic and histologic evidence in the past; if prior confirmation is not available, this must be done at the time of screening endoscopy. After the screening visits, eligible patients will be randomized to 1 of 3 study groups: (1) IBD98 M 0.8 g/day (mesalamine 0.8 g with sodium hyaluronate 92 mg), (2) IBD98 M 1.2 g/day (mesalamine 1.2 g with sodium hyaluronate 138 mg), or (3) placebo. Up to 51 patients will be enrolled in this study (including drop-out patients), with 17 patients randomized to each treatment group. Patients will be encouraged to take their medication at the same time every day.

During the study, patients will visit the clinic on 7 occasions: 2 visits during the screening period (the second screening visit is the baseline visit); 4 visits during the treatment period, Visits 3, 4, 5, and 6/early termination at Weeks 0, 2, 4, and 6; and 1 visit at the end of the follow-up period, Visit 7 at Week 8. Patients will record the dates/times of dosing (after randomization), concomitant medication, and symptoms and adverse events (AEs) in a daily diary starting at Visit 1 and continuing until the end of treatment (Visit 6/early termination). Rescue medication will not be permitted during the 6 weeks of the treatment period, and patients who are considered to not be benefiting from the therapy can be withdrawn and assigned an appropriate alternative UC treatment by the Investigator. Compliance will be assessed throughout the study by determining the amount of unused medication. Records will be kept of all medication dispensed, used, and returned by each patient. At the end of the study, all unused trial medication and used packaging will be returned to the Sponsor. All study medication will be accounted for and any discrepancies documented.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative Colitis
Study Start Date : January 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Mesalamine

Arm Intervention/treatment
Experimental: High dose
High dose, twice a day for 6 weeks.
Drug: High dose
6 capsules of IBD98-M, twice a day
Other Name: Mesalamine-Sodium Hyaluronic 200 mg-23 mg

Placebo Comparator: Placebo: C
Placebo, twice a day
Drug: Placebo
Placebo

Experimental: Low dose
Low dose, twice a day for 6 weeks
Drug: Low dose
4 capsules of IBD98-M
Other Name: Mesalamine-Sodium Hyaluronic 200 mg-23 mg




Primary Outcome Measures :
  1. Remission Rate [ Time Frame: 6 weeks ]

    Percentage of patients in remission over a 6-week treatment period. Remission is defined as a modified UCDAI (Ulcerative Colitis Disease Activity Index) score of ≤1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1).

    Modified UCDAI scoring system is sum of following 4 subscores (parameters). Higher score means worst disease condition.

    Rectal bleeding: score 1 (Streaks of blood), score 2 (obvious blood), score 3 (Mostly Blood) Stool frequency: score 1 (1-2/day> normal), score 2 (3-4/day >normal), score 3 (>4/day> normal) Mucosal appearance: score 1 (Erythema, decreased vascular pattern, Minimal granularity), score 2 (Marked erythema, Friability, Granularity, Absent vascular pattern, Bleeding minimal trauma, No ulcerations), score 3 (Ulceration Spontaneous bleeding) Physician's Global Assessment: score 1 (mild), score 2 (Moderate), score 3 (Severe)



Secondary Outcome Measures :
  1. Improvement Rate [ Time Frame: 6 weeks ]

    Clinical improvement over a 6-weeks treatment period was defined as a ≥ 3 point reduction from Baseline in the modified UCDAI (Ulcerative Colitis Disease Activity Index ) score.

    Modified UCDAI scoring system is sum of following 4 subscores (parameters). Higher score means worst disease condition.

    Rectal bleeding: score 1 (Streaks of blood), score 2 (obvious blood), score 3 (Mostly Blood) Stool frequency: score 1 (1-2/day> normal), score 2 (3-4/day >normal), score 3 (>4/day> normal) Mucosal appearance: score 1 (Erythema, decrased vascular pattern, Minimal granularity), score 2 (Marked erythema, Friability, Granularity, Absent vascular pattern, Bleeding minimal trauma, No ulcerations), score 3 (Ulceration Spontaneous bleeding) Physician's Global Assessment: score 1 (mild), score 2 (Moderate), score 3 (Severe)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, age ≥18 and <75 years, suffering from UC for at least 6 months prior to screening
  2. Female patients must be postmenopausal, sterile, or have a negative urine pregnancy test prior to entering the study and use adequate contraception during the study if of childbearing potential.
  3. Diagnosis of active UC with UCDAI ≥4 and ≤10, with endoscopy score of ≥1 in the UCDAI mucosal appearance subscore

Exclusion Criteria:

  1. Patients diagnosed with Crohn's disease, indeterminate colitis, or ischemic colitis
  2. Female patients who are pregnant or breastfeeding
  3. Ulcerative proctitis with ≤15 cm of disease
  4. Patients with infectious colitis as determined by assessment for Clostridium difficile (C. difficile) and fecal pathogens at screening or treatment for C. difficile within 30 days prior to screening
  5. History of or current evidence of toxic megacolon, fulminant colitis (e.g., Lichtiger score of ≥10), colonic perforation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493712


Locations
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Italy
Istituto Clinico Humanitas
Milan, Italy
Sponsors and Collaborators
Holy Stone Healthcare Co., Ltd
inVentiv Health Clinical
Investigators
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Principal Investigator: Silvio Danese Istituto Clinico Humanitas
  Study Documents (Full-Text)

Documents provided by Holy Stone Healthcare Co., Ltd:
Study Protocol  [PDF] March 24, 2015
Statistical Analysis Plan  [PDF] December 13, 2017

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Responsible Party: Holy Stone Healthcare Co., Ltd
ClinicalTrials.gov Identifier: NCT02493712    
Other Study ID Numbers: IBD98-M-2002
First Posted: July 9, 2015    Key Record Dates
Results First Posted: August 14, 2020
Last Update Posted: August 14, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents