Ulcerative ColitisPhase 3PROTECT-1NCT02142725
Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis
A Phase 3 study testing LT-02 in people with Ulcerative Colitis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- LT-02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jul 2014to 16 Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of ulcerative colitis
- Active ulcerative colitis disease extent ≥ 15 cm
- Active disease despite treatment with mesalamine
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
Frankfurt a.M., 60431
About this study
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
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.
- Conditions
- Ulcerative Colitis
- Being tested
- LT-02, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-02Drug
four times per day
LT-02Drug
two times per day
PlaceboDrug
four times per day
| Study group | Role | What they receive |
|---|---|---|
| LT-02 | Experimental | LT-02 0.8g four times daily Receives: Drug: LT-02 |
| B: LT-02 | Experimental | LT-02 1.6g twice daily Receives: Drug: LT-02 |
| Placebo | Placebo comparator | LT-02 Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical remission
Measured: 12 weeks
Secondary outcomes (8)
Rate of patients with clinical improvement
Measured: 12 weeks
Time to first resolution of symptoms
Measured: 12 weeks
Number of stools per week
Measured: 12 weeks
Number of days with urgency per week
Measured: 12 weeks
Rate of mucosal healing
Measured: 12 weeks
Rate of histologic remission
Measured: 12 weeks
Physician's global assessment at final visit
Measured: 12 weeks
Quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study start21 Jul 2014
- Primary completion11 Nov 2016
- Study completion16 Dec 2016
Why it stopped: IDMC recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Dignass, MD, Principal investigator, Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142725
- Sponsor's protocol ID
- PCG-2/UCA
- Other IDs
- 2012-003702-27
- Acronym
- PROTECT-1
- Status last verified
- Feb 2017
- First submitted
- 15 May 2014
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dignass A, Stremmel W, Horynski M, Poyda O, Armerding P, Fellermann K, Langhorst J, Kuehbacher T, Uebel P, Stein J, Novacek G, Avalueva E, Oliinyk O, Hasselblatt P, Dorofeyev A, Heinemann H, Mueller R, Greinwald R, Reinisch W; International PROTECT-1/2 Study Groups. Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials. Clin Gastroenterol Hepatol. 2024 Apr;22(4):810-820.e7. doi: 10.1016/j.cgh.2023.09.031. Epub 2023 Oct 6.
PubMed 37806372
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02142725
- Acronym / sponsor ID
- PROTECT-1 / PCG-2/UCA
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IDMC recommendation
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2014 (actual)
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LT-02 | Experimental | Drug: LT-02LT-02 0.8g four times daily |
| B: LT-02 | Experimental | Drug: LT-02LT-02 1.6g twice daily |
| Placebo | Placebo comparator | Drug: PlaceboLT-02 Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of ulcerative colitis
- Active ulcerative colitis disease extent ≥ 15 cm
- Active disease despite treatment with mesalamine
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LT-02four times per day | Drug | LT-02 |
| LT-02two times per day | Drug | B: LT-02 |
| Placebofour times per day | Drug | Placebo |
Primary outcome
Rate of clinical remission
Time frame: 12 weeks
8 secondary outcomes
Rate of patients with clinical improvement
Time frame: 12 weeks
Time to first resolution of symptoms
Time frame: 12 weeks
Number of stools per week
Time frame: 12 weeks
Number of days with urgency per week
Time frame: 12 weeks
Rate of mucosal healing
Time frame: 12 weeks
Rate of histologic remission
Time frame: 12 weeks
Physician's global assessment at final visit
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: IDMC recommendation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Derived from this study: PubMed 37806372Dignass A, Stremmel W, Horynski M, Poyda O, Armerding P, Fellermann K, Langhorst J, Kuehbacher T, Uebel P, Stein J, Novacek G, Avalueva E, Oliinyk O, Hasselblatt P, Dorofeyev A, Heinemann H, Mueller R, Greinwald R, Reinisch W; International PROTECT-1/2 Study Groups. Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials. Clin Gastroenterol Hepatol. 2024 Apr;22(4):810-820.e7. doi: 10.1016/j.cgh.2023.09.031. Epub 2023 Oct 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Dignass, MD principal investigator
Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LT-02 in people with Ulcerative Colitis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: IDMC recommendation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical remission (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02142725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.