PROTECT-1: Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis

• Sponsor: Dr. Falk Pharma GmbH (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02142725
• Collaborator: (none)
• Enrollment: 468
• Location: 1
• Arms: 3
• Actual Duration (Months): 28.9
• Patients Per Site Per Month: 16.2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 468 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 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
• Actual Study Start Date: Jul 21, 2014
• Actual Primary Completion Date: Nov 11, 2016
• Actual Study Completion Date: Dec 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LT-02 LT-02 0.8g four times daily	Drug: LT-02; four times per day
Experimental: B: LT-02 LT-02 1.6g twice daily	Drug: LT-02; two times per day
Placebo Comparator: Placebo LT-02 Placebo	Drug: Placebo; four times per day

Outcome Measures

Primary Outcome Measures

1. Rate of clinical remission [12 weeks]

Secondary Outcome Measures

1. Rate of patients with clinical improvement [12 weeks]

2. Time to first resolution of symptoms [12 weeks]

3. Number of stools per week [12 weeks]

4. Number of days with urgency per week [12 weeks]

5. Rate of mucosal healing [12 weeks]

6. Rate of histologic remission [12 weeks]

7. Physician's global assessment at final visit [12 weeks]

8. Quality of life [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Established diagnosis of ulcerative colitis

• Active ulcerative colitis disease extent ≥ 15 cm

• Active disease despite treatment with mesalamine

Exclusion Criteria:

• Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis,

• Toxic megacolon or fulminant colitis

• Colon resection

• Evidence of infectious colitis

• Celiac disease

• Bleeding hemorrhoids

• 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

• Any relevant known systemic disease

• History of cancer in the last five years

• Abnormal hepatic function or liver cirrhosis

• Abnormal HbA1c at screening visit

• Patients with known hypersensitivity to soy

• Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)

• Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins

• Treatment with other investigational drug

• Existing or intended pregnancy or breast-feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine	Frankfurt a.M.		Germany	60431

Sponsors and Collaborators

• Dr. Falk Pharma GmbH

Investigators

• Principal Investigator: Axel Dignass, MD, Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Falk Pharma GmbH
• ClinicalTrials.gov Identifier: NCT02142725
• Other Study ID Numbers: PCG-2/UCA; 2012-003702-27
• First Posted: May 20, 2014
• Last Update Posted: Feb 9, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

No Results Posted as of Feb 9, 2017