NCT02368717 is a Phase 3 clinical trial of Mesalazine Enema in Ulcerative Colitis, sponsored by Ferring Pharmaceuticals.

Who is sponsoring NCT02368717?

NCT02368717 is sponsored by Ferring Pharmaceuticals.

What drugs are being tested in NCT02368717?

Interventions in NCT02368717: Mesalazine Enema, Placebo Enema.

What condition does NCT02368717 study?

NCT02368717 studies Ulcerative Colitis.

Is NCT02368717 still recruiting?

NCT02368717 is currently completed. Last updated 10 October 2017.

Last reviewed 2017-10-10 · How we verify

NCT02368717

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets

Completed Phase 3 Last updated 10 October 2017

What this trial tests

Phase 3 trial testing Mesalazine Enema in Ulcerative Colitis in 281 participants. Completed in 25 July 2017.

Timeline

1 March 2015

Primary endpoint
5 January 2017

25 July 2017

Quick facts

Lead sponsor	Ferring Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	281
Start date	1 March 2015
Primary completion	5 January 2017
Estimated completion	25 July 2017
Sites	1 location across China

Drugs / interventions tested

Mesalazine Enema — full drug profile →
Placebo Enema

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

Adults 18 to 70, 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.

Clinical remission after 4 weeks treatment
Time frame: At week 4
Defined as a total Mayo score ≤2 points, with no subscore \>1 point

Sponsor's own description

The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02368717 (US National Library of Medicine, public domain)
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: 10 October 2017

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/NCT02368717.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing