Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002557-35 | EudraCT Number |
Not provided
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Not provided
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The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesalamine | Experimental | 4 g extended release granules (sachet) |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalamine | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Remission | The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which assessed subject's symptoms and ranged between 0-6, and Endoscopic Response which assessed objective evidence of inflammation and ranged between 0-3. Further, the Clinical Response component included two subscales: stool frequency and rectal bleeding (each ranged between 0-3 each) obtained from subjects' daily records. The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy (ranging between 0-3). | At Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score) | The Modified Mayo score was calculated as the sum of the Clinical and Endoscopic Response Score (Range: 0-9, and the standard PGA score (range: 0-3; normal [score=0], mild disease [score=1], moderate disease [score=2], severe disease [score=3]). The statistical test was to be conducted only if the primary analysis was significant. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preferred Research Partners | Little Rock | Arkansas | United States | |||
| United Research Institute |
A total of 411 subjects were screened, of which 228 subjects were randomized in a 1:1 ratio to either mesalamine or placebo group (114 subjects each), for 8 weeks double-blind treatment.
Subjects who completed 8 weeks but failed to meet the defined criteria for remission received open-label treatment with mesalamine for additional 8 weeks.
A total of 71 sites in 10 countries (Bulgaria, Canada, Hungary, Latvia, Mexico, Russia, Serbia, Switzerland, Ukraine, and United States) recruited subjects to this trial between October 2015 to November 2017, the last subject completed last visit in April 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mesalamine | Mesalamine 4 gram (g) extended release granules (sachet), administered orally once daily (QD) |
| FG001 | Placebo | Placebo 4 g to match mesalamine extended release granules, administered orally QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2017 | Jan 8, 2021 |
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| At Week 8 |
| Time to Cessation of Rectal Bleeding | Defined as time in days from randomization to the first day of 3 consecutive days with a rectal bleeding score of 0, based on subject's daily diary. The statistical test was to be conducted only if the primary analysis was significant. | Up to Week 8 |
| The Proportion of Subjects With Endoscopic Improvement | Defined as an Endoscopic Response Score of 0 or 1, with at least a 1 point reduction from baseline in the endoscopic score at Week 8. | At Week 8 |
| The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8 | Defined as a score of 0 for rectal bleeding and 0 or 1 with at least 1 point decrease from baseline for stool frequency in the Clinical Response Score subset. | At Week 2, 4, and 8 |
| Time to Normal Stool Pattern | Defined as time in days from randomization to the first day of 3 consecutive days with a stool frequency score of 0, based on subject daily diary. | Up to Week 8 |
| The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8 | Defined as change from baseline in rectal bleeding score at Week 2, 4, and 8 based on subject daily diary. Rectal Bleeding Score is graded 0-3, where 0 is best. | From baseline to Week 2, 4, and 8 |
| The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8 | The adjusted mean changes in serum CRP levels from baseline and their difference between treatment groups are presented for each time point. | From baseline to Week 2, 4, and 8 |
| The Change From Baseline in Fecal Calprotectin Levels at Week 8 | The adjusted mean change from baseline in fecal calprotectin levels at Week 8 are presented. | From baseline to Week 8 |
| The Change From Baseline in Health Related Quality of Life (QoL) Scores | The change from baseline to Week 2, 4, and 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) scores. The adjusted changes from baseline and their differences between treatment groups are presented. The IBDQ is an instrument used to assess quality of life in adult patients with UC. Subjects were asked to recall symptoms and QoL from last two weeks and to rate each item on a 7- point Likert score (higher scores equate to higher QoL). | From baseline to Week 2, 4, and 8 |
| Number of Participants Experiencing Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in a clinical trial. A 'treatment-emergent AE (TEAE)' is defined as an AE which occurs in the time interval from initial dosing (investigational medicinal product [IMP] intake) to the end of treatment visit. Proportion of subjects with any TEAE (serious or non-serious) are presented. | Up to Week 16 |
| Severity of Adverse Events | The proportion of subjects with intensity of AEs (classified as mild, moderate or severe) are presented. | Up to Week 16 |
| Proportion of Subject With Abnormal Laboratory Values (Hematology) | Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented. >= greater than equal to; <= less than equal to. | Up to Week 16 |
| Proportion of Subjects With Abnormal Laboratory Values (Coagulation) | Proportion of subjects with markedly abnormal changes from baseline values in coagulation laboratory values are presented. INR= International normalized ratio. | Up to Week 16 |
| Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry) | Proportion of subjects with markedly abnormal changes in serum chemistry laboratory values are presented. ALT= Alanine aminotransferase; AST= Aspartate aminotransferase; BUN= Blood urea nitrogen; GGT= Gamma glutamyl transferase. | Up to Week 16 |
| Murrieta |
| California |
| United States |
| Research Associates of South Florida, LLC | Miami | Florida | United States |
| IMIC | Palmetto Bay | Florida | United States |
| Medical Research Center of Florida | Pembroke Pines | Florida | United States |
| Lenus Research and Medical Group | Sweetwater | Florida | United States |
| Clinical Trials of SWLA, LLC | Lake Charles | Louisiana | United States |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | United States |
| Wilmington Gastroenterology Associates | Wilmington | North Carolina | United States |
| Associates in Gastroenterology, PLC | Hermitage | Tennessee | 37076 | United States |
| Quality Medical Research, PLLC | Nashville | Tennessee | United States |
| BI Research Center | Houston | Texas | United States |
| Biopharma Informatic Inc. | Houston | Texas | United States |
| Digestive Health Center | Pasadena | Texas | United States |
| DM Clinical Research | Tomball | Texas | United States |
| Advanced Research Institute | Ogden | Utah | United States |
| New River Valley Research Institute | Christiansburg | Virginia | United States |
| Digestive & Liver Disease Specialists | Norfolk | Virginia | United States |
| Multiprofile Hospital For Active Treatment Avis Medica | Pleven | Bulgaria |
| Medical Center Excelsior OOD | Sevlievo | Bulgaria |
| Medical Center-1-Sevlievo EOOD | Sevlievo | Bulgaria |
| City Clinic University Multiprofile Hospital for Active Treatment EOOD | Sofia | Bulgaria |
| Medical Center Asklepion - Humane Medicine Research EOOD | Sofia | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD | Sofia | Bulgaria |
| University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD | Sofia | Bulgaria |
| Diagnostic Consultative Centre Mladost M OOD | Varna | Bulgaria |
| Topstone Research Institute | Ottawa | Ontario | Canada |
| Toronto Digestive Disease Associates | Vaughan | Canada |
| Magyar Honvédség Egészségügyi Központ | Budapest | Hungary |
| Pannónia Magánorvosi Centrum Kft | Budapest | Hungary |
| Semmelweis Egyetem Institute | Budapest | Hungary |
| Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja | Debrecen | Hungary |
| ENDOMEDIX Kft. | Miskolc | Hungary |
| Karolina Korhaz Rendelointezet | Mosonmagyaróvár | Hungary |
| Clinfan Kft. | Szekszárd | Hungary |
| Polana-D, LTD | Daugavpils | Latvia |
| Digestive Diseases Centre Gastro | Riga | Latvia |
| Latvian Maritime Medicine Centre | Riga | Latvia |
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
| Riga East Clinical University Hospital | Riga | Latvia |
| ICARO Investigaciones en Medicina, S.A de C.V | Chihuahua City | Mexico |
| Maria Auxiliadora Hospital | Guadalajara | Mexico |
| Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V. | Zapopan | Mexico |
| Osrodek Medycyny Rodzinnej Sp. z o.o. | Sobótka | Lower Silesian Voivodeship | Poland |
| Lexmedica | Wroclaw | Lower Silesian Voivodeship | Poland |
| Zespół Przychodni Specjalistycznych PRIMA Sp. z o.o. | Warsaw | Masovian Voivodeship | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Podlaskie Voivodeship | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomeranian Voivodeship | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej Intermed | Częstochowa | Poland |
| Economicus - NZOZ ALL-MEDICUS | Katowice | Poland |
| Investigational site | Ksawerów | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny | Lodz | Poland |
| SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | Poland |
| Investigational site | Sopot | Poland |
| Centrum Zdrowia Matki, Dziecka i Mlodziezy | Warsaw | Poland |
| Regional Clinical Hospital | Krasnoyarsk | Russia |
| City Clinical Hospital #51 | Moscow | Russia |
| Nizhegorodskaya Regional Clinical Hospital n.a. Semashko | Nizhny Novgorod | Russia |
| Novosibirsk State Medical University | Novosibirsk | Russia |
| Research Institute of Physiology of Sibirian Branch the RAMS | Novosibirsk | Russia |
| Omsk State Medical Academy | Omsk | Russia |
| Rostov State Medical University | Rostov-on-Don | Russia |
| State Budget Institution of Ryazan region" Regional Clinical Hospital" | Ryazan | Russia |
| City Hospital #31 | Saint Petersburg | Russia |
| City Polyclinic #38 | Saint Petersburg | Russia |
| Russian Medical Military Academy n.a. S.M. Kirov | Saint Petersburg | Russia |
| Railway Clinical Hospital at Station Samara OAO Rzhd | Samara | Russia |
| Stavropol State Medical Academy | Stavropol | Russia |
| Clinical Hospital Centar Zvezdara | Belgrade | Serbia |
| Health Center Valjevo | Valjevo | Serbia |
| Inselspital Bern | Bern | Switzerland |
| Investigational site | Bern | Switzerland |
| Universitätsspital Zürich | Zurich | Switzerland |
| Kyiv Municipal Clinical Hospital #18 | Kyiv | Kyïv | Ukraine |
| Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv | Kyiv | Kyïv | Ukraine |
| Regional Municipal Institution Chernivtsi Regional Clinical Hospital | Chernivtsi | Ukraine |
| Municipal Institution Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov | Dnipropetrovsk | Ukraine |
| Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 | Kharkiv | Ukraine |
| SI National Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine | Kharkiv | Ukraine |
| Municipal Intitution "Kherson City Clinical Hospital n.a. A. and O. Tropinykh" | Kherson | Ukraine |
| Private Enterprise Private Manufactire Company "Acinus". | Kirovohrad | Ukraine |
| Kremenchuk city Hospital # n.a O.T.Bohaievskyi | Kremenchuk | Ukraine |
| Kyiv City Clinical Hospital #8 | Kyiv | Ukraine |
| Kyiv Municipal Clinical Hospital #18 | Kyiv | Ukraine |
| Medical Center Universal Clinic Oberih of LLC Kapytal | Kyiv | Ukraine |
| Municipal City Clinical emergency Hospital | Lviv | Ukraine |
| Municipal Institution Odesa Regional Clinical Hospital | Odesa | Ukraine |
| Medical Clinical Research Center of Medical Center LLC Health Clinic | Vinnytsia | Ukraine |
| Small Business Private Enterprise Medical Center "Pulse" | Vinnytsia | Ukraine |
| Vinnytsia Regional Clinical Hospital Hospital n.a. M.I. Pyrohov | Vinnytsia | Ukraine |
| Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council | Zaporizhzhia | Ukraine |
| Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council | Zaporizhzhia | Ukraine |
| Medical Centre of PE First Private Clinic | Zhytomyr | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-label |
|
|
The Intention-to-treat (ITT) analysis set comprised all randomized subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mesalamine | Mesalamine 4 g extended release granules (sachet), administered orally QD |
| BG001 | Placebo | Placebo 4 g to match mesalamine extended release granules, administered orally QD |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Stool Frequency Score | Stool Frequency Score is graded 0-3, where 0 is best. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||||
| Rectal Bleeding Score | Rectal Bleeding Score is graded 0-3, where 0 is best. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||||
| Endoscopic Response Score | Endoscopic Response Score is graded 0-3, where 0 is best. | Mean | Standard Deviation | scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects With Remission | The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which assessed subject's symptoms and ranged between 0-6, and Endoscopic Response which assessed objective evidence of inflammation and ranged between 0-3. Further, the Clinical Response component included two subscales: stool frequency and rectal bleeding (each ranged between 0-3 each) obtained from subjects' daily records. The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy (ranging between 0-3). | The ITT analysis set comprised all randomized subjects. | Posted | Count of Participants | Participants | At Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score) | The Modified Mayo score was calculated as the sum of the Clinical and Endoscopic Response Score (Range: 0-9, and the standard PGA score (range: 0-3; normal [score=0], mild disease [score=1], moderate disease [score=2], severe disease [score=3]). The statistical test was to be conducted only if the primary analysis was significant. | The ITT analysis set comprised all randomized subjects. | Posted | Count of Participants | Participants | At Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Cessation of Rectal Bleeding | Defined as time in days from randomization to the first day of 3 consecutive days with a rectal bleeding score of 0, based on subject's daily diary. The statistical test was to be conducted only if the primary analysis was significant. | The ITT analysis set comprised all randomized subjects. | Posted | Median | 95% Confidence Interval | days | Up to Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Subjects With Endoscopic Improvement | Defined as an Endoscopic Response Score of 0 or 1, with at least a 1 point reduction from baseline in the endoscopic score at Week 8. | The ITT analysis set comprised randomized subjects. | Posted | Count of Participants | Participants | At Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8 | Defined as a score of 0 for rectal bleeding and 0 or 1 with at least 1 point decrease from baseline for stool frequency in the Clinical Response Score subset. | The ITT analysis comprised all randomized subjects. | Posted | Count of Participants | Participants | At Week 2, 4, and 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Normal Stool Pattern | Defined as time in days from randomization to the first day of 3 consecutive days with a stool frequency score of 0, based on subject daily diary. | The ITT analysis set comprised randomized subjects. | Posted | Median | 95% Confidence Interval | days | Up to Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8 | Defined as change from baseline in rectal bleeding score at Week 2, 4, and 8 based on subject daily diary. Rectal Bleeding Score is graded 0-3, where 0 is best. | The ITT analysis set comprised randomized subjects. | Posted | Mean | Standard Deviation | scores on a scale | From baseline to Week 2, 4, and 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8 | The adjusted mean changes in serum CRP levels from baseline and their difference between treatment groups are presented for each time point. | The ITT analysis set comprise all randomized subjects. | Posted | Mean | Standard Deviation | mg/L | From baseline to Week 2, 4, and 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Change From Baseline in Fecal Calprotectin Levels at Week 8 | The adjusted mean change from baseline in fecal calprotectin levels at Week 8 are presented. | The ITT analysis set comprised all randomized subjects. | Posted | Mean | Standard Deviation | ug/g | From baseline to Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Change From Baseline in Health Related Quality of Life (QoL) Scores | The change from baseline to Week 2, 4, and 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) scores. The adjusted changes from baseline and their differences between treatment groups are presented. The IBDQ is an instrument used to assess quality of life in adult patients with UC. Subjects were asked to recall symptoms and QoL from last two weeks and to rate each item on a 7- point Likert score (higher scores equate to higher QoL). | The ITT analysis set comprised randomized subjects. | Posted | Mean | Standard Deviation | points on a score | From baseline to Week 2, 4, and 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in a clinical trial. A 'treatment-emergent AE (TEAE)' is defined as an AE which occurs in the time interval from initial dosing (investigational medicinal product [IMP] intake) to the end of treatment visit. Proportion of subjects with any TEAE (serious or non-serious) are presented. | The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received. | Posted | Count of Participants | Participants | Up to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Severity of Adverse Events | The proportion of subjects with intensity of AEs (classified as mild, moderate or severe) are presented. | The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received. | Posted | Count of Participants | Participants | Up to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subject With Abnormal Laboratory Values (Hematology) | Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented. >= greater than equal to; <= less than equal to. | The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received. | Posted | Count of Participants | Participants | Up to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Abnormal Laboratory Values (Coagulation) | Proportion of subjects with markedly abnormal changes from baseline values in coagulation laboratory values are presented. INR= International normalized ratio. | The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received. | Posted | Count of Participants | Participants | Up to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry) | Proportion of subjects with markedly abnormal changes in serum chemistry laboratory values are presented. ALT= Alanine aminotransferase; AST= Aspartate aminotransferase; BUN= Blood urea nitrogen; GGT= Gamma glutamyl transferase. | The safety analysis set comprised all subjects who received at least 1 dose of IMP, and was analyzed according to actual treatment received. | Posted | Count of Participants | Participants | Up to Week 16 |
|
|
TEAE occurred in the time interval from initial dosing (IMP intake) to the end of trial visit, up to 8 weeks for the Mesalamine and Placebo Arms and an additional 8 weeks for the Open-Label extension period.
TEAEs were defined as AE which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mesalamine | Mesalamine 4 g extended release granules (sachet), administered orally QD | 0 | 114 | 1 | 114 | 19 | 114 |
| EG001 | Placebo | Placebo 4 g to match mesalamine extended release granules, administered orally QD | 0 | 114 | 0 | 114 | 13 | 114 |
| EG002 | Mesalamine (Open-Label) | Mesalamine 4 g extended release granules (sachet), administered orally QD | 0 | 170 | 2 | 170 | 8 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tracheitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Faecal calprotectin increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2018 | Jan 8, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| 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 |
Not provided
Not provided
| Adverse Event |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
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