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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001205-84 | EudraCT Number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LT-02 | Experimental | LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily |
|
| Placebo | Placebo Comparator | LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily |
|
| Mesalamine | Active Comparator | LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LT-02 | Drug | LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who are relapse-free and are not a treatment failure | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the total mDAI | 48 weeks |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Axel Dignass, Prof Dr | Agaplesion Markus Krankenhaus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agaplesion Markus-Krankenhaus | Frankfurt a.M. | 60431 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37806372 | Derived | 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. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Placebo |
| Drug |
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily |
|
| Mesalamine | Drug | LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |