A Phase 3 interventional study of Budesonide granules 9 mg and Placebo granules in Incomplete Microscopic Colitis, sponsored by Dr. Falk Pharma GmbH. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by Dr. Falk Pharma GmbH · Phase 3, Interventional, and Treatment
The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.
23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.
This study's enrollment of 44 is close to the median of 47 across 14 interventional studies indexed under Colitis, Microscopic.
Browse Colitis, Microscopic studies →Dr. Falk Pharma GmbH is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Budesonide granules 9 mg
Drug: Budesonide granules 9 mg
Placebo granules
Drug: Placebo granules
per day
per day
Rate of clinical remission
Time frame: 8 weeks
Rate of clinical remission
Time frame: 2 weeks
Rate of clinical remission
Time frame: 6 weeks
Time to remission
Time frame: 8 weeks
Number of formed/soft/watery stools per week
Time frame: 8 weeks
Number of days with abdominal pain
Time frame: 8 weeks
Number of days with urgency
Time frame: 8 weeks
Rate of histological remission
Time frame: 8 weeks
Physician's global assessment at final visit
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
The record gives a start of May 2014, a primary completion of Feb 2020 and a completion of Feb 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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