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NCT02522767
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis
Phase 3 trial testing Mesalamine in Ulcerative Colitis in 228 participants. Completed in 3 April 2018.
6 February 2018
Quick facts
| Lead sponsor | Ferring Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 228 |
| Start date | 1 October 2015 |
| Primary completion | 6 February 2018 |
| Estimated completion | 3 April 2018 |
| Sites | 93 locations across United States, Bulgaria, Canada, Hungary, Latvia, Mexico, Poland, Russia |
Drugs / interventions tested
- Mesalamine — full drug profile →
- Placebo
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Ferring Pharmaceuticals — full company profile →
Who can join
Adults 18 to 75, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Proportion of Subjects With Remission
Time frame: At Week 8
The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which asse
Sponsor's own description
The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.
Murray A, Nguyen TM, Parker CE, Feagan BG, et al · · 2020 · cited 51× · PMID 32786164 · DOI 10.1002/14651858.cd000543.pub5
Verify or expand the search:
- PubMed search for NCT02522767
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mesalamine
Trials testing the same drug.
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- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07064707 — Rupatadine in Patients With Ulcerative Colitis · Phase 2 · recruiting
- NCT06993974 — Nitazoxanide in Patients With Ulcerative Colitis · Phase 2 · recruiting
- NCT06525974 — Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated Wi · EARLY_PHASE1 · not yet recruiting
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
- NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
- NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Ferring Pharmaceuticals trials
Trials by the same sponsor.
- NCT07152730 — A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump · Phase 1 · withdrawn
- NCT07029451 — To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patt · recruiting
- NCT06668493 — Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis · Phase 1, PHASE2 · recruiting
- NCT06545955 — A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in · Phase 3 · recruiting
- NCT06510374 — Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Can · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02522767 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ferring Pharmaceuticals
- Last refreshed: 19 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02522767.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing