Ulcerative Colitis Clinical Trial
Official title:
Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice
| Verified date | April 2011 |
| 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 of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).
| Status | Completed |
| Enrollment | 338 |
| Est. completion date | March 2011 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients suffering from ulcerative colitis Exclusion Criteria: - Hypersensitivity to mesalazine, salicylates or to any excipient - Severe damage to liver or renal functions |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Hospital Brandýs n/Lab. | Brandys nad Labem | |
| Czech Republic | Hospital Breclav | Breclav | |
| Czech Republic | Faculty Hospital U Sv. Anny Brno | Brno | |
| Czech Republic | Investigational site | Ceské Budejovice | |
| Czech Republic | Investigational site | Chomutov | |
| Czech Republic | Hospital Chrudim | Chrudim | |
| Czech Republic | Hospital. Frýdek- Místek | Frýdek- Místek | |
| Czech Republic | Investigational site | Hodonín | |
| Czech Republic | Investigational site | Hradec Králové | |
| Czech Republic | Hospital Karviná | Karviná | |
| Czech Republic | Investigational site | Litomerice | |
| Czech Republic | Hospitál Mladá Bolesl | Mladá Boleslav | |
| Czech Republic | Faculty Hospital Olomouc | Olomouc | |
| Czech Republic | Investigational site | Ostrava | |
| Czech Republic | Vítkovická Hospital | Ostrava | |
| Czech Republic | Gastromedic s.r.o.,ul. | Pardubice | |
| Czech Republic | Faculty Hospital Bpry Plzen | Plzen | |
| Czech Republic | Faculty Hospital Lochotín Plzen | Plzen | |
| Czech Republic | Faculty Hospital Motol, Praha 5 | Praha | |
| Czech Republic | NMSB, Praha 1 | Praha | |
| Czech Republic | Poliklinika Prosek, Praha | Praha | |
| Czech Republic | Thomayerova hospital., Praha 4 | Praha | |
| Czech Republic | ÚVN, Praha 6 | Praha | |
| Czech Republic | VFN, Praha 2 | Praha | |
| Czech Republic | Investigational site | Prerov | |
| Czech Republic | Hospital Svitavy | Svitavy | |
| Czech Republic | Provincial hospital, Kpt. | Tábor | |
| Czech Republic | Investigational site | Ústí n.Labem | |
| Czech Republic | Hospital T. Bati Zlín | Zlín | |
| Czech Republic | Hospital Znojmo | Znojmo |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
Czech Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Verify the safety profile | Number of AEs/SAEs Intensity and seriousness of reported AEs/SAEs |
1 year | 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 |