A Study With Pentasa in Patients With Active Crohn's Disease

NCT00862121 | Terminated Phase 3 Results

• 2 other identifiers: FE999907 CS05EudraCT no: 2008-002100-26
• Study Type: interventional
• Target: 20
• Locations: 7 countries
• Sites: 15

Brief Summary

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.

Conditions

Crohn´s Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Relative Change From Baseline to Week 10 in Fecal Calprotectin

  At Week 10, end of treatment

• Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)

  Within the 10 week treatment period

• Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score

  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)

  Within the 10 week treatment period

• Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance

  At Week 10, end of treatment

Study Arms (2)

Mesalazine

EXPERIMENTAL

Mesalazine (Mesalamine) 2 g sachet; 6 g daily

Drug: Pentasa

Placebo

PLACEBO COMPARATOR

Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily

Drug: Placebo

Interventions

Pentasa DRUG

6 g/day orally, 2 g in the morning and 4 g in the evening

Mesalazine

Placebo DRUG

6 g/day orally, 2 g in the morning and 4 g in the evening

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: at least 18 years
• CD symptoms/onset of disease: ≥ 3 months prior to Visit 1
• Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease
• A confirmed location of CD (by MRI, X-ray (small bowel and/or colon), and/or endoscopy)
• A Harvey-Bradshaw score between 5 and 12
• Males and non-pregnant, non-nursing women
• Mild to moderate active CD, defined by a CDAI score between 180 and 350
• Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g)
• Estimated creatinine clearance should be above 75 ml/min

You may not qualify if:

• Any significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient's ability to participate in the trial
• CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine, and/or to colon below the left colon flexure and/or isolated proctitis and/or anal disease
• Prior treatment resistance to Pentasa (mesalazine)
• Chronic, dominant arthralgia or rheumatoid arthritis
• Palpable abdominal mass
• Biologics (eg anti-TNF-α) must not be used during the trial or 6 months before Visit 1
• Continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year
• Positive pregnancy test

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (15)

San Diego Clinical Trials

San Diego, California, United States

Location

Clinical Research of West Florida

Clearwater, Florida, United States

Location

Atlanta Gastroenterology Specialists

John's Creek, Georgia, United States

Location

Center for Digestive and Liver Disease, Inc

Mexico, Montana, United States

Location

Wake Research Associates

Raleigh, North Carolina, United States

Location

Consultants for Clinical Research Inc.

Cincinnati, Ohio, United States

Location

Hartwell Research Group, LLC

Anderson, South Carolina, United States

Location

CHC Saint Joseph

Liège, Belgium

Location

Herlev University Hospital

Copenhagen, Denmark

Location

Investigational Site

Lille, France

Location

Investigational Site

Berlin, Germany

Location

Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln

Cologne, Germany

Location

Gemeinschaftspraxis

Leipzig, Germany

Location

Lunds Lasaret

Lund, Sweden

Location

Addenbrookes Hospital

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Limitations and Caveats

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.

Results Point of Contact

• Title: Ferring Pharmaceuticals
• Organization: Clinical Development Support

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 16, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 16, 2012
• Results First Posted: March 12, 2012

Record last verified: 2012-03

Locations

US (7); BE (1); FR (1); DK (1); DE (3); SE (1); GB (1)