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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT no: 2008-002100-26 |
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Terminated due to poor recruitment
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The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesalazine | Experimental | Mesalazine (Mesalamine) 2 g sachet; 6 g daily |
|
| Placebo | Placebo Comparator | Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentasa | Drug | 6 g/day orally, 2 g in the morning and 4 g in the evening |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10. | The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to <150 or a decrease in CDAI score of at least 70. | At Week 10, end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change From Baseline to Week 10 in Fecal Calprotectin | Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation. | At Week 10, end of treatment |
| Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP) |
Not provided
Inclusion Criteria (main):
Exclusion Criteria (main):
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Clinical Trials | San Diego | California | United States | |||
| Clinical Research of West Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mesalazine | Mesalazine (Mesalamine) 2 g sachet; 6 g daily |
| FG001 | Placebo | Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Mesalazine | Mesalazine (Mesalamine) 2 g sachet; 6 g daily |
| BG001 | Placebo | Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily |
| 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 |
| 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 | Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10. | The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to <150 or a decrease in CDAI score of at least 70. | The percentage of CDAI responders at Week 10 was analysed for the FAS (treated participants with post-baseline CDAI), Last Observation Carried Forward (LOCF). | Posted | Number | percentage of participants | At Week 10, end of treatment |
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mesalazine | Mesalazine (Mesalamine) 2 g sachet; 6 g daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.0 |
Early termination led to small number of participants (20/510; actual/planned). Only the primary efficacy outcome was subject to formal statistical analysis. No conclusions could be drawn on primary and secondary efficacy analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ferring Pharmaceuticals | Clinical Development Support | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
Not provided
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| Placebo |
| Drug |
6 g/day orally, 2 g in the morning and 4 g in the evening |
|
Serum CRP is a laboratory measure of acute inflammation. Higher values are worse. |
| Within the 10 week treatment period |
| Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score | The IBDQ is a measure of the impact of inflammatory bowel disease (IBD) on health-related quality-of-life (HRQL; mood, social activities, daily life, and IBD-related health worries). Higher scores are better; Total IBDQ score can range from 32 (very poor HRQL) to 224 (perfect HRQL). | Within the 10 week treatment period |
| Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity) | The WPAI_CD Item 5 measures the impact of Crohn's disease on work productivity (while working). The score is recorded by the patient on a visual analog scale, from 0 to 10. Lower scores are better, while higher scores indicate greater negative effect on work productivity. | Within the 10 week treatment period |
| Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance | A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula. | At Week 10, end of treatment |
| Clearwater |
| Florida |
| United States |
| Atlanta Gastroenterology Specialists | John's Creek | Georgia | United States |
| Center for Digestive and Liver Disease, Inc | Mexico | Montana | United States |
| Wake Research Associates | Raleigh | North Carolina | United States |
| Consultants for Clinical Research Inc. | Cincinnati | Ohio | United States |
| Hartwell Research Group, LLC | Anderson | South Carolina | United States |
| CHC Saint Joseph | Liège | Belgium |
| Herlev University Hospital | Copenhagen | Denmark |
| Investigational Site | Lille | France |
| Investigational Site | Berlin | Germany |
| Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln | Cologne | Germany |
| Gemeinschaftspraxis | Leipzig | Germany |
| Lunds Lasaret | Lund | Sweden |
| Addenbrookes Hospital | Cambridge | United Kingdom |
| Protocol Violation |
|
| Exclusion criterion violation |
|
| Incorrect randomisation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily |
|
|
|
| Secondary | Relative Change From Baseline to Week 10 in Fecal Calprotectin | Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation. | Full Analysis Set (FAS), observed cases (OC), descriptive statistics only. | Posted | Mean | Standard Deviation | microgram/gram faeces | At Week 10, end of treatment |
|
|
|
| Secondary | Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP) | Serum CRP is a laboratory measure of acute inflammation. Higher values are worse. | Full Analysis Set (OC). Descriptive statistics only. | Posted | Mean | Standard Deviation | mg/L | Within the 10 week treatment period |
|
|
|
| Secondary | Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score | The IBDQ is a measure of the impact of inflammatory bowel disease (IBD) on health-related quality-of-life (HRQL; mood, social activities, daily life, and IBD-related health worries). Higher scores are better; Total IBDQ score can range from 32 (very poor HRQL) to 224 (perfect HRQL). | Full Analysis Set (OC). Descriptive statistics only. | Posted | Mean | Standard Deviation | IBDQ score | Within the 10 week treatment period |
|
|
|
| Secondary | Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity) | The WPAI_CD Item 5 measures the impact of Crohn's disease on work productivity (while working). The score is recorded by the patient on a visual analog scale, from 0 to 10. Lower scores are better, while higher scores indicate greater negative effect on work productivity. | Full Analysis Set (OC). Descriptive statistics only. | Posted | Mean | Standard Deviation | WPAI_CD Item 5 score | Within the 10 week treatment period |
|
|
|
| Secondary | Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance | A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula. | Safety Analysis Set (OC). Descriptive statistics only. | Posted | Mean | Standard Deviation | mL/min | At Week 10, end of treatment |
|
|
|
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | Placebo | Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily | 0 | 11 | 7 | 11 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (12.0) |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA (12.0) |
|
| Gastrointestinal hypermotility | Gastrointestinal disorders | MedDRA (12.0) |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (12.0) |
|
| Sinusitis | Infections and infestations | MedDRA (12.0) |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
|
| Headache | Nervous system disorders | MedDRA (12.0) |
|
| Depression | Psychiatric disorders | MedDRA (12.0) |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (12.0) |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
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.
| 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 |