Crohn´s DiseasePhase 3PEACENCT00862121
A Study With Pentasa in Patients With Active Crohn's Disease
A Phase 3 study testing Pentasa in people with Crohn´s Disease, run by Ferring Pharmaceuticals at 15 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn´s Disease
- What is being tested?
- Pentasa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 15 sitesin 7 countries
- Study dates
- Apr 2009to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
United States7 sites
Hartwell Research Group, LLC
Anderson, South Carolina
Consultants for Clinical Research Inc.
Cincinnati, Ohio
Clinical Research of West Florida
Clearwater, Florida
Atlanta Gastroenterology Specialists
John's Creek, Georgia
Center for Digestive and Liver Disease, Inc
Mexico, Montana
Wake Research Associates
Raleigh, North Carolina
San Diego Clinical Trials
San Diego, California
Germany3 sites
Investigational Site
Berlin
Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln
Cologne
Gemeinschaftspraxis
Leipzig
About this study
Official title: PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.
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
- Being tested
- Pentasa, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentasaDrug
6 g/day orally, 2 g in the morning and 4 g in the evening
PlaceboDrug
6 g/day orally, 2 g in the morning and 4 g in the evening
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine | Experimental | Mesalazine (Mesalamine) 2 g sachet; 6 g daily Receives: Drug: Pentasa |
| Placebo | Placebo comparator | Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 10, end of treatment
Secondary outcomes (5)
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.
Measured: At Week 10, end of treatment
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At Week 10, end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Terminated due to poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn´s DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862121
- Sponsor's protocol ID
- FE999907 CS05
- Other IDs
- EudraCT no: 2008-002100-26
- Acronym
- PEACE
- Status last verified
- Mar 2012
- First submitted
- 13 Mar 2009
- Last updated
- 16 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.
- ClinicalTrials.gov ID
- NCT00862121
- Acronym / sponsor ID
- PEACE / FE999907 CS05
- Conditions
- Crohn´s Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to poor recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Mar 2009 (estimated)
- Results
- Posted 12 Mar 2012
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesalazine | Experimental | Drug: PentasaMesalazine (Mesalamine) 2 g sachet; 6 g daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Pentasa6 g/day orally, 2 g in the morning and 4 g in the evening | Drug | Mesalazine |
| Placebo6 g/day orally, 2 g in the morning and 4 g in the evening | Drug | Placebo |
Primary outcome
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.
Time frame: At Week 10, end of treatment
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.
5 secondary outcomes
Relative Change From Baseline to Week 10 in Fecal Calprotectin
Time frame: At Week 10, end of treatment
Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)
Time frame: Within the 10 week treatment period
Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time frame: 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)
Time frame: Within the 10 week treatment period
Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance
Time frame: At Week 10, end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pentasa in people with Crohn´s Disease, run by Ferring Pharmaceuticals at 15 sites in 7 countries.
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 9 inclusion and 8 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Belgium, Denmark, France and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10. (time frame: At Week 10, end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2012.