NCT01517594CompletedNot Applicable
Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 568
- Locations
- 30
- Primary Endpoint
- verify the safety profile: measured by number of AEs/SAEs
Study Overview
Brief Summary
Confirmation of safety profile
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •treatment of Ulcerative Colitis
Exclusion Criteria
- •hypersensitivity to mesalazine
- •severe liver or renal impairment
Outcomes
Primary Outcomes
verify the safety profile: measured by number of AEs/SAEs
Time Frame: 12 months from patient recruitment
Secondary Outcomes
- dosage: evaluate dosage level(12 months from patient recruitment)
Investigators
Study Sites (30)
Loading locations...
Similar Trials
Completed
Not Applicable
A Study of Pentasa in Patients With Ulcerative ColitisUlcerative ColitisNCT01104753Ferring Pharmaceuticals338
Completed
Phase 1
Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants StudyHealthy VolunteersNCT02461160Takeda88
Unknown
Phase 1
A Safety，Tolerability and Pharmacokinetics Clinical Trial of JX11502MA CapsuleSchizophreniaNCT05233657Zhejiang Jingxin Pharmaceutical Co., Ltd.58
Active, not recruiting
Phase 2
A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)Progressive Supranuclear PalsyNCT04993768Transposon Therapeutics, Inc.40
Completed
Phase 1
A Study to Evaluate the Safety and Pharmacokinetics of HH-120 Nasal Spray in Healthy VolunteersCOVID-19NCT05753878Huahui Health62