Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)

Sponsor

Dr. Falk Pharma GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT02280629

Collaborator

(none)

150

Enrollment

Location

Arms

48.1

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: LT-02 Drug: Placebo Drug: Mesalamine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Oct 5, 2018

Actual Study Completion Date :

Oct 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LT-02 LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily	Drug: LT-02 LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
Placebo Comparator: Placebo LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily	Drug: Placebo LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
Active Comparator: Mesalamine LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily	Drug: Mesalamine LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily

Arm

Intervention/Treatment

Experimental: LT-02

LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily

Drug: LT-02

LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily

Placebo Comparator: Placebo

LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily

Drug: Placebo

LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily

Active Comparator: Mesalamine

LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily

Drug: Mesalamine

LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily

Outcome Measures

Primary Outcome Measures

Percentage of patients who are relapse-free and are not a treatment failure [48 weeks]

Secondary Outcome Measures

Mean change from baseline in the total mDAI [48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Major Inclusion Criteria:

Signed informed consent
Men or women, 18 to 70 years of age
Historically confirmed diagnosis of UC by endoscopy and histology
Patients being in clinical and endoscopical remission at baseline
Negative pregnancy test in females of childbearing potential at baseline visit

Major Exclusion Criteria:

Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis
Toxic megacolon or fulminant colitis
Colon resection
Malabsorption syndromes
Celiac disease
Bleeding hemorrhoids
Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding
History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
Any severe concomitant renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
Any relevant known systemic disease (e.g., AIDS, active tuberculosis)
Severe co-morbidity substantially reducing life expectancy
History of cancer in the last five years
Abnormal hepatic function at screening visit, liver cirrhosis
Abnormal renal function at screening visit
Patients with known hypersensitivity to soy
Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine)
Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization
Treatment with methotrexate within last 6 weeks prior to randomization
Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization
Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization
Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02
Existing or intended pregnancy or breast-feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Agaplesion Markus-Krankenhaus	Frankfurt a.M.		Germany	60431

Sponsors and Collaborators

Dr. Falk Pharma GmbH

Investigators

Principal Investigator: Axel Dignass, Prof Dr, Agaplesion Markus Krankenhaus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Falk Pharma GmbH

ClinicalTrials.gov Identifier:

NCT02280629

Other Study ID Numbers:

PCG-4/UCR
2013-001205-84

First Posted:

Oct 31, 2014

Last Update Posted:

Jan 27, 2020

Last Verified:

Jan 1, 2020

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2020