A Phase 3 interventional study of Budesonide (6 mg) and Budesonide (9 mg) in Colitis, Ulcerative, sponsored by Ferring Pharmaceuticals. Completed at 72 sites in Japan. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-18.
Sponsored by Ferring Pharmaceuticals · Phase 3, Interventional, and Treatment
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Among 10 studies testing budesonide in Colitis, Ulcerative — 1 open to participants now, 1 under way, none of them phase 3. Budesonide · Colitis, Ulcerative.
Among the 10 studies testing budesonide in Colitis, Ulcerative, this one is the 4th largest by enrollment, is the only one that started in 2018, is one of 6 in phase 3, and was the 8th registered.
1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.
Browse Colitis, Ulcerative studies →1 of the 10 studies testing budesonide in Colitis, Ulcerative is open now, in 1 country. Recruiting first, the newest first:
Bausch Health Americas, Inc. · Sites in United States
Ages 5–17
By country, each count listing its studies:
Budesonide: first FDA approval 1994 (RHINOCORT), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.
This study: 16 Years to 75 Years · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 7 · Phase 4 1
First in 2007; this study’s year is marked. 1 started in 2018.
This study's enrollment of 274 is above the median of 70 across 1,237 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 183 across the 10 interventional studies. Of the 8 that completed or were terminated, 5 (63%) have results posted.
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8 of 10 have an industry lead sponsor. The 5 most frequent:
Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
19 studies in Colitis, Ulcerative by Ferring Pharmaceuticals: none open now, none under way, none of them phase 3. Of 18 finished, 3 (17%) have results posted.
Among the 19 studies in Colitis, Ulcerative by Ferring Pharmaceuticals, this one is the 5th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2018, is one of 7 in phase 3, and was the 16th registered.
Ferring Pharmaceuticals’s Colitis, Ulcerative studies by the year they started, since 2005.
1 of the studies testing budesonide in Colitis, Ulcerative that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04314375Bausch Health Americas, Inc.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 | 2026-12 |
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Among the 10 studies testing budesonide in Colitis, Ulcerative, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Ferring Pharmaceuticals’s 19 in Colitis, Ulcerative:
Nothing recorded among them since 2026-09-25.
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To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Budesonide (6 mg)
Drug: Budesonide (9 mg)
Drug: Mesalazine (3,600 mg)
Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Also known as: FE 999315
Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Also known as: FE 999315
Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.
Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score
UCDAI is a four-component scale, used to determine the severity of ulcerative colitis. The four components assessed are stool frequency, rectal bleeding, mucosal appearance and physician's rating of disease activity. Score for each component can range between 0-3 and thus, the maximum overall score can be between 0-12. Higher score implies higher disease severity.
Time frame: After 8 weeks
Percentage of subjects achieving clinical remission after 8 weeks of treatment
Time frame: 8 weeks
Percentage of subjects achieving 0 score for subscores of rectal bleeding, stool frequency and mucosal appearance (normal mucosa) in UCDAI after 8 weeks of treatment
Time frame: 8 weeks
Percentage of subjects achieving clinical improvement after 8 weeks of treatment
Time frame: 8 weeks
Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1
Time frame: 8 weeks
Percentage of subjects achieving symptom resolution after 2 weeks of treatment
Time frame: 2 weeks
Percentage of subjects achieving symptom resolution after 4 weeks of treatment
Time frame: 4 weeks
Percentage of subjects achieving symptom resolution after 8 weeks of treatment
Time frame: 8 weeks
Percentage of subjects with endoscopic healing after 8 weeks of treatment
Time frame: 8 weeks
Change from baseline in partial UCDAI score at 2 weeks
Time frame: 2 weeks
Change from baseline in partial UCDAI score at 4 weeks
Time frame: 4 weeks
Change from baseline in partial UCDAI score at 8 weeks
Time frame: 8 weeks
Ran from Mar 2018 to primary completion in May 2020, 26 months.
Of 87 industry-sponsored phase 3 interventional studies under Colitis, Ulcerative, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 70. This study's 26 months is below that.
Counting every sponsor, half of 101 studies reached it within 48 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Budesonide