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Budesonide 9 mg Capsules in Active UC (TOPICAL-1)

Primary Purpose

Colitis, Ulcerative

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Budesonide

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent,
Men or women aged 18 to 75 years,
Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
Established disease,

Exclusion Criteria:

Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
Toxic megacolon or fulminant colitis,
Colon resection,
Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
Malabsorption syndromes,
Celiac disease,
Bleeding hemorrhoids,
Active peptic ulcer disease
Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
Any severe infectious disease (e.g., tuberculosis, AIDS),
Severe co-morbidity substantially reducing life expectancy,
History of colorectal cancer,
History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma

Sites / Locations

University of Schleswig-Holstein

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Budesonide

Arm Description

Outcomes

Primary Outcome Measures

Rate of clinical remission at final/withdrawal visit

Clinical remission includes normalisation of stool frequency and absence of blood in stools

Secondary Outcome Measures

Rate of endoscopic remission/improvement at final/withdrawal visit

Number of stools / bloody stools per week

Full Information

NCT ID

NCT02550418

First Posted

September 14, 2015

Last Updated

July 25, 2017

Sponsor

Dr. Falk Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02550418

Brief Title

Budesonide 9 mg Capsules in Active UC

Acronym

TOPICAL-1

Official Title

Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colitis, Ulcerative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Budesonide

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Budesonide

Primary Outcome Measure Information:

Title

Rate of clinical remission at final/withdrawal visit

Description

Clinical remission includes normalisation of stool frequency and absence of blood in stools

Time Frame

8 weeks treatment

Secondary Outcome Measure Information:

Title

Rate of endoscopic remission/improvement at final/withdrawal visit

Time Frame

8 weeks treatment

Title

Number of stools / bloody stools per week

Time Frame

8 weeks treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent, Men or women aged 18 to 75 years, Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology, Established disease, Exclusion Criteria: Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis, Toxic megacolon or fulminant colitis, Colon resection, Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening), Malabsorption syndromes, Celiac disease, Bleeding hemorrhoids, Active peptic ulcer disease Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured, Any severe infectious disease (e.g., tuberculosis, AIDS), Severe co-morbidity substantially reducing life expectancy, History of colorectal cancer, History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klaus Fellermann, MD

Organizational Affiliation

University Hospital Schleswig-Holstein

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Schleswig-Holstein

City

Lübeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

33028169

Citation

Fellermann K, Schiefke I, Racz I, Derova J, Jonaitis L, Wehrum S, Nacak T, Greinwald R. Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1). United European Gastroenterol J. 2020 Dec;8(10):1186-1195. doi: 10.1177/2050640620962632. Epub 2020 Oct 7.

Results Reference

derived

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Budesonide 9 mg Capsules in Active UC

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