A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis
- Conditions
- Active, mild to moderate ulcerative colitisMedDRA version: 18.1Level: LLTClassification code 10058816Term: Colitis ulcerative acute episodeSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-002557-35-BE
- Lead Sponsor
- Ferring International PharmaScience Center U.S., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
1. Male or nonpregnant female subjects aged 18 to 75 years
2. Newly diagnosed or recurrent mild to moderate UC as defined by Modified Mayo score of =4 but not >10 and a score of =2 for flexible sigmoidoscopy
3. Extent of colonic involvement as confirmed by flexible sigmoidoscopy; colonoscopy performed only if flexible sigmoidoscopy cannot establish the upper border of UC involvement
4. Negative stool test at screening to rule out parasites, bacterial pathogens, and Clostridium difficile. Subjects who test positive for Clostridium difficile can be rescreened if treated and Clostridium difficile negative for 2 consecutive months.
5. Estimated creatinine clearance >60 mL/min
6. Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal
intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Sterilized or postmenopausal women may also participate. Women must have a negative serum pregnancy test result at screening and negative urine pregnancy test result at Visit 1 (baseline/randomization)
7. Signed informed consent obtained before any trial-related procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Use of oral 5-ASA products at a dose >2.5 g/day or topical rectal 5-ASA within the past 7 days
2. Disease limited to proctitis <15 cm
3. Short bowel syndrome
4. Prior colon resection surgery
5. History of severe/fulminant UC
6. Evidence of other forms of inflammatory bowel disease
7. Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
8. Intolerant or allergic to aspirin or salicylate derivatives
9. Taking the following treatments:
a. Aspirin within the past 7 days (except for cardioprotective reasons - maximum dose 325 mg/day)
b. Loperamide and other antidiarrheal agents, mucilages, antibiotics (metronidazole and ciprofloxacin), nonsteroidal anti-inflammatory drugs (NSAIDs), nicotine patch within 1 week
c. Corticosteroids (oral, intravenous, or intramuscular) within the previous month
d. Immunomodulating/suppressing drugs within the previous 6 months
e. Use of rectal formulations (5-ASA, steroids) within <7 days
f. History of biologics (e.g., Remicade)
10. ALT; AST >3 x upper limit of normal (ULN)
11. Clinically significant hematological function abnormalities
12. Known alcohol or drug abuse
13. Women who are pregnant or nursing
14. History of or known malignancy (Note: Adequately treated basal cell carcinoma can be included)
15. History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial
16. Participation in another clinical trial in the last 30 days
17. Unable to comply with the requirements of the protocol
18. Unable to complete the subject electronic diary or follow data-capturing procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate efficacy of mesalamine 4 g extended release granules (sachet) once daily (QD) in the induction of clinical and endoscopic remission versus placebo in subjects with active, mild to moderate ulcerative colitis (UC);Secondary Objective: - To evaluate the efficacy of mesalamine 4 g extended release granules (sachet) using the Clinical and Endoscopic Response Score and the Clinical Response Score subset<br>- To assess health-related quality of life<br>- To assess the incidence and severity of adverse events;Primary end point(s): The primary efficacy endpoint is the proportion of subjects with remission, defined by the Clinical and Endoscopic Response Score based on a modified 9 point Mayo Score.;Timepoint(s) of evaluation of this end point: At week 8
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Key secondary endpoints:<br>1. The proportion of subjects with remission in the primary endpoint and the Physician’s Global Assessment (PGA) at Week 8<br>2. Time to cessation of rectal bleeding<br>Secondary endpoints:<br>1. The proportion of subjects in clinical remission at Weeks 2, 4, and 8<br>2. Time to normal stool pattern <br>3. The change from baseline in the health-related quality of life <br>4. Safety assessed by incidence and severity of AEs;Timepoint(s) of evaluation of this end point: Key secondary endpoints:<br>1- Week 8<br>2- From randomization to the first day of 3 consecutive days with a rectal bleeding score of 0.<br>Secondary endpoints:<br>1- Weeks 2,4 and 8<br>2- From randomization to the first day of 3 consecutive days with a stool frequency score of 0<br>3- From baseline to each scheduled assessment of the health-related quality of life <br>4- From Signing of informed consent