Ulcerative Colitis Clinical Trial
Official title:
Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic
| Verified date | October 2013 |
| Source | Ferring Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Czech Republic: State Institute for Drug Control |
| Study type | Observational |
Confirmation of safety profile
| Status | Completed |
| Enrollment | 568 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - treatment of Ulcerative Colitis Exclusion Criteria: - hypersensitivity to mesalazine - severe liver or renal impairment |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Hospital Breclav | Breclav | |
| Czech Republic | FN sv.Anna | Brno | |
| Czech Republic | Gastroenterologická ambulance | Brno | |
| Czech Republic | Hospital Milosrdných bratrí | Brno | |
| Czech Republic | Nemocnice Cheb | Cheb | |
| Czech Republic | Gastroenterologická ambulance Hodonín | Hodonín | |
| Czech Republic | Hospital TGM Hodonín | Hodonín | |
| Czech Republic | FN, II. Interní klinika | Hradec Králové | |
| Czech Republic | Oblastní nemoncice Jicín | Jicín | |
| Czech Republic | Nemocnice Karlovy Vary | Karlovy Vary | |
| Czech Republic | Nemocnice s poliklinikou Ráj | Karviná | |
| Czech Republic | Gastroenterologická ambulance Jezuitská | Litomerice | |
| Czech Republic | Gastroenterologická ambulance Litomerice | Litomerice | |
| Czech Republic | GASTRO MED, s.r.o. | Ostrava | |
| Czech Republic | Gastromedic s.r.o. | Pardubice | |
| Czech Republic | 4. poliklinika Plzen, Gastroenterologická ambulance | Plzen | |
| Czech Republic | Ústrední vojenská nemocnice | Praha | |
| Czech Republic | Poliklinika - gastroenterologie | Praha 1 | |
| Czech Republic | Fakultní poliklinika VFN | Praha 2 | |
| Czech Republic | Sanatorium sv. Anny | Praha 3 | |
| Czech Republic | FN Motol | Praha 5 | |
| Czech Republic | Iscare | Praha 7 | |
| Czech Republic | Poliklinika Clinicum - Interna | Praha 9 | |
| Czech Republic | Poliklinika Mens | Prerov | |
| Czech Republic | Hospital Prostejov | Prostejov | |
| Czech Republic | Poliklinika - gastroenterologie Rychnov nad Knežnou | Rychnov nad Knežnou | |
| Czech Republic | Masarykova nemocnice,Interna | Ústí nad labem | |
| Czech Republic | Nemocnice Valašské Mezirící | Valašské Mezirící | |
| Czech Republic | Vítkovická nemocnice | Vítkovice | |
| Czech Republic | Krajská nemocnice T.Bati | Zlín |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
Czech Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | verify the safety profile: measured by number of AEs/SAEs | 12 months from patient recruitment | Yes | |
| Secondary | dosage: evaluate dosage level | 12 months from patient recruitment | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05702879 -
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
|
||
| Not yet recruiting |
NCT05953402 -
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
|
||
| Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
| Recruiting |
NCT03950232 -
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
| Completed |
NCT03124121 -
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
|
Phase 4 | |
| Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
| Withdrawn |
NCT04209556 -
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
|
Phase 2 | |
| Terminated |
NCT00061282 -
Clotrimazole Enemas for Pouchitis in Children and Adults
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04398550 -
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
|
N/A | |
| Recruiting |
NCT04314375 -
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
|
Phase 4 | |
| Active, not recruiting |
NCT04857112 -
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
|
Phase 2 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Active, not recruiting |
NCT04033445 -
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
| Active, not recruiting |
NCT06221995 -
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
|
||
| Recruiting |
NCT04767984 -
Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
|
Phase 2 | |
| Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
| Recruiting |
NCT06071312 -
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
|
Phase 1/Phase 2 | |
| Completed |
NCT03760003 -
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
|
Phase 2 | |
| Not yet recruiting |
NCT05539625 -
Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis
|
Phase 2 |