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Trial record 1 of 1 for:    IBD98-M | Ulcerative Colitis | Italy
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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Colitis, Ulcerative
Interventions Drug: High dose
Drug: Low dose
Drug: Placebo
Enrollment 51
Recruitment Details Started recruitment on 2016/01/01 Completed recruitment on 2018/07/01
Pre-assignment Details No patient was excluded before assignment to groups.
Arm/Group Title High Dose Placebo: C Low Dose
Hide Arm/Group Description

High dose, twice a day for 6 weeks.

High dose: 6 capsules of IBD98-M, twice a day

Placebo, twice a day

Placebo: Placebo

Low dose, twice a day for 6 weeks

Low dose: 4 capsules of IBD98-M

Period Title: Overall Study
Started 16 18 17
Completed 14 12 11
Not Completed 2 6 6
Reason Not Completed
Withdrawal by Subject             1             0             2
Protocol Violation             0             0             1
Lost to Follow-up             1             0             0
Physician Decision             0             1             0
Lack of Efficacy             0             5             3
Arm/Group Title High Dose Placebo: C Low Dose Total
Hide Arm/Group Description

High dose, twice a day for 6 weeks.

High dose: 6 capsules of IBD98-M, twice a day

Placebo, twice a day

Placebo: Placebo

Low dose, twice a day for 6 weeks

Low dose: 4 capsules of IBD98-M

Total of all reporting groups
Overall Number of Baseline Participants 16 18 17 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 17 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  93.8%
17
  94.4%
17
 100.0%
49
  96.1%
>=65 years
1
   6.3%
1
   5.6%
0
   0.0%
2
   3.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 18 participants 17 participants 51 participants
43.5
(22 to 69)
47.5
(21 to 69)
35
(20 to 54)
45
(20 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 17 participants 51 participants
Female
9
  56.3%
9
  50.0%
5
  29.4%
23
  45.1%
Male
7
  43.8%
9
  50.0%
12
  70.6%
28
  54.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 17 participants 51 participants
Hispanic or Latino
0
   0.0%
1
   5.6%
2
  11.8%
3
   5.9%
Not Hispanic or Latino
16
 100.0%
17
  94.4%
15
  88.2%
48
  94.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 17 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   5.9%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   5.6%
1
   5.9%
2
   3.9%
White
16
 100.0%
17
  94.4%
15
  88.2%
48
  94.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 17 participants 51 participants
16 18 17 51
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 16 participants 18 participants 17 participants 51 participants
16 18 17 51
1.Primary Outcome
Title Remission Rate
Hide Description

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)

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The percentage of patients in remission at Week 6 is summarized for the ITT population.
Arm/Group Title High Dose Group Low Dose Group Placebo
Hide Arm/Group Description:
IBD98-M 1.2 g/day group
IBD98-M 0.8 g/day group
Placebo capsule, 6 capsules/day
Overall Number of Participants Analyzed 16 17 18
Measure Type: Count of Participants
Unit of Measure: Participants
2
  12.5%
1
   5.9%
2
  11.1%
2.Secondary Outcome
Title Improvement Rate
Hide Description

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)

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Group Low Dose Group Placebo
Hide Arm/Group Description:
IBD98-M 1.2 g/day group
IBD98-M 0.8 g/day group
Placebo capsule, 6 capsules/day
Overall Number of Participants Analyzed 16 17 18
Measure Type: Count of Participants
Unit of Measure: Participants
5
  31.3%
3
  17.6%
3
  16.7%
Time Frame up to 8 weeks - 6 weeks treatment and 2 weeks follow-up
Adverse Event Reporting Description The gastro disorder is not the high risk for mortality
 
Arm/Group Title High Dose Group Low Dose Group Placebo
Hide Arm/Group Description IBD98-M 1.2 g/day group IBD98-M 0.8 g/day group Placebo capsule, 6 capsules/day
All-Cause Mortality
High Dose Group Low Dose Group Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/17 (0.00%)      0/18 (0.00%)    
Hide Serious Adverse Events
High Dose Group Low Dose Group Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/17 (0.00%)      1/18 (5.56%)    
Gastrointestinal disorders       
WORSENING OF ULCERATIVE COLITIS * 1 [1]  0/16 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
[1]
(N)Gastrointestinal disorders Colitis ulcerative WORSENING OF ULCERATIVE COLITIS
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Dose Group Low Dose Group Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/16 (37.50%)      8/17 (47.06%)      8/18 (44.44%)    
Gastrointestinal disorders       
Colitis ulcerative * 1 [1]  0/16 (0.00%)  0 5/17 (29.41%)  5 3/18 (16.67%)  3
Abdominal pain * 1 [2]  3/16 (18.75%)  3 1/17 (5.88%)  1 3/18 (16.67%)  3
Nausea * 1 [3]  1/16 (6.25%)  1 1/17 (5.88%)  1 3/18 (16.67%)  3
Dyspesia * 1 [4]  2/16 (12.50%)  2 0/17 (0.00%)  0 1/18 (5.56%)  1
Vomiting * 1 [5]  0/16 (0.00%)  0 1/17 (5.88%)  1 1/18 (5.56%)  1
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
[1]
Colitis ulcerative
[2]
Abdominal pain
[3]
Nausea
[4]
Dyspesia
[5]
vomiting
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: YUCHIH, Chen
Organization: Holy Stone Healthcare Co., Ltd
Phone: 886287975966 ext 272
EMail: ivychen@hshc.com.tw
Layout table for additonal information
Responsible Party: Holy Stone Healthcare Co., Ltd
ClinicalTrials.gov Identifier: NCT02493712    
Other Study ID Numbers: IBD98-M-2002
First Submitted: July 7, 2015
First Posted: July 9, 2015
Results First Submitted: March 9, 2020
Results First Posted: August 14, 2020
Last Update Posted: August 14, 2020