T-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Phase 1

• Conditions: Acute Ulcerative Colitis (UC); MedDRA version: 16.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-003702-27-BE
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-04
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 762

Inclusion Criteria

Principle
- Men or women, 18 to 70 years of age,
- Established diagnosis of UC, based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings,
- Active UC with disease extent = 15 cm (proctitis only patients to be excluded), confirmed by endoscopy and histology,
- Mesalamine (5-ASA) refractory disease,
- Elevated stool calprotectin at screening.

Inclusion criteria for open-label sub-study:
The following inclusion criterion will apply only to the open label sub-study:
1. Patients not in remission of UC at week 12, or patients withdrawn = 8 weeks after randomization due to lack of efficacy and
showing no clinical improvement.
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 720
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

Principle
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
diverticular disease associated colitis,
- Colon resection,
- Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
- History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack,
- Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization,
- Treatment with methotrexate within last 6 weeks prior to randomization,
- Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization,
- Treatment with rectal corticosteroid formulation within last 2 weeks prior to randomization,
- Concomitant treatment with coumarins (e.g., phenprocoumon),
- Existing or intended pregnancy or breast-feeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified