Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02586259
Other study ID # 000217
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2015
Est. completion date April 5, 2018

Study information

Verified date November 2019
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in routine clinical practice and its effectiveness and tolerability in a real-life setting.


Recruitment information / eligibility

Status Completed
Enrollment 378
Est. completion date April 5, 2018
Est. primary completion date April 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Men and women aged = 18 years

- Outpatients

- Patients who have been prescribed Cortiment® for the treatment of mild to moderate active ulcerative colitis within a 5 days' time window prior to being included in the study

- Patients who have received adequate information regarding this non-interventional study and are able to understand and voluntarily sign the Informed Consent

Exclusion Criteria:

- Patients with severe active / fulminant ulcerative colitis

- Patients treated with antibiotics or corticosteroids for the current flare. Use of Antibiotics for other conditions non-related to the gastrointestinal tract, either before enrolment or during the observational period is permitted.

- History of total / sub-total colectomy

- Hypersensitivity to the active substance, lecithin (derived soya oil, peanut oil) or to any of the excipients

- Patients enrolled and involved in an interventional study

- Patients whom investigators consider inappropriate to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
budesonide MMX®


Locations

Country Name City State
Canada Digestive Health Clinic (there may be other sites in this country) Richmond Hill
Germany Magen-Darm-Zentrum, Facharztzentrum Eppendorf (there may be other sites in this country) Hamburg
Ireland St. Vincent's University Hospital (there may be other sites in this country) Dublin
Italy Investigational site (there may be other sites in this country) Bologna
Netherlands Investigational site (there may be other sites in this country) Amsterdam
Poland Investigational site (there may be other sites in this country) Warszawa
Sweden Danderyds sjukhus (there may be other sites in this country) Stockholm
United Kingdom Kings College Hospital (there may be other sites in this country) London

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Germany,  Ireland,  Italy,  Netherlands,  Poland,  Sweden,  United Kingdom, 

References & Publications (1)

Danese S, Hart A, Dignass A, Fiorino G, Louis E, Bonovas S, D'Haens G, Dotan I, Rogler G, Paridaens K, Peyrin-Biroulet L. A multicentre prospective cohort study assessing the effectiveness of budesonide MMX® (Cortiment®(MMX®)) for active, mild-to-moderate — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical benefit in routine practice, defined as % of patients with clinical improvement = 3-point in Ulcerative Colitis Disease Activity Index (UCDAI) clinical sub-score From Day 1 to end of induction treatment (recommended duration up to 8 weeks)
See also
  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