Ulcerative ColitisPhase 3NCT00073021
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
A Phase 3 study testing Asacol 800 mg (mesalamine) and Asacol 400 mg (mesalamine) in people with Ulcerative Colitis, run by Warner Chilcott at 57 sites in 3 countries.
Trial summary
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Asacol 800 mg (mesalamine) and Asacol 400 mg (mesalamine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 57 sitesin 3 countries
- Study dates
- Sep 2000to Sep 2003
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female between 18 and 75 years of age;
- have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
- currently demonstrating moderately active disease
Who cannot join
- Patients will be excluded from admission to the study if they have/are:
- a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- a history of extensive small bowel resection (>1/2 the length of the small intestine) causing short bowel syndrome;
- current renal or hepatic disease;
- participated in any drug or device clinical study within 30 days of entry;
- currently enrolled in any other clinical study;
Show all 13Show fewer
- received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
- received any other topical rectal therapy during the week prior to the Screening Visit;
- received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
- received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
- received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
- received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
- if female, positive pregnancy test, or lactating.
Trial locations and contacts
57 sites in 3 countries.
57 sites in 3 countries
United States54 sites
Research Site
Altoona, Pennsylvania, 16602
AGMG Clinical Research
Anaheim, California, 92801
Digestive Disorders Associates
Annapolis, Maryland, 21401
Research Site
Arvada, Colorado, 80002
Research Site
Austin, Texas, 78705
Research Site
Baltimore, Maryland, 21215
Digestive Disease Associates
Baltimore, Maryland, 21229
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Carolinas Digestive Health Associates
Charlotte, North Carolina, 28262
Charlottesville Medical Research
Charlottesville, Virginia, 22902
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815
University of Chicago Medical Center
Chicago, Illinois, 60637
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Research Site
Cincinnati, Ohio, 45267
Research Site
Columbus, Ohio, 43215
Research Site
Dallas, Texas, 75246
GI & Liver Consultants
Dayton, Ohio, 45440
Henry Ford Hospital
Detroit, Michigan, 48202
Research Site
Englewood, Colorado, 80110
Research Site
Fairfax, Virginia, 22031
Research Site
Forest Hills, New York, 11375
Research Site
Fredericksburg, Virginia, 22401
Long Island Clinical Research Associates
Great Neck, New York, 11021
Research Site
Hanover, Pennsylvania, 17331
PharmaTrials, Inc.
Hillsborough, New Jersey, 08844
Center for GI Disorders
Hollywood, Florida, 33021
Research Site
Houston, Texas, 77030
Houston Medical Research Associates
Houston, Texas, 77090
Regional Research Institute
Jackson, Tennessee, 38305
Research Site
Los Angeles, California, 90067
Research Site
Maitland, Florida, 32789
Center for Medical Research, LLC
Manchester, Connecticut, 06040
Southeast Research Associates
Marietta, Georgia, 30067
GI Research
Metairie, Louisiana, 70001
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207
Research Site
New York, New York, 10128
Research Site
Ogden, Utah, 84405
Research Site
Oklahoma City, Oklahoma, 73190
Community Clinical Trials
Orange, California, 38305
AGMG Clinical Research
Orange, California, 92869
Advanced Gastroenterology Associates
Palm Harbor, Florida, 34684
West Hills Gastroenterology Group
Portland, Oregon, 97225
Research Site
Raleigh, North Carolina, 27612
Richmond GI Research
Richmond, Virginia, 23226
Mayo Clinic
Rochester, Minnesota, 55905
Research Site
Sacramento, California, 95825
Sharp Rees-Stealy Medical Group
San Diego, California, 92123
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
Louisiana Research Center
Shreveport, Louisiana, 71103
Research Site
Spokane, Washington, 99207
Research Site
Statesville, North Carolina, 28677
Research Site
Temple, Texas, 76508
Research Site
Tulsa, Oklahoma, 74135
Research Site
Zephyrhills, Florida, 33540
Canada2 sites
Research Site
Richmond, British Columbia, V7C 5L9
Research Site
Toronto, Ontario, M5B 1W8
Puerto Rico1 site
University of Puerto Rico, School of Medicine
San Juan, 00935
About this study
Official title: A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
- Conditions
- Ulcerative Colitis
- Being tested
- Asacol 800 mg (mesalamine), Asacol 400 mg (mesalamine)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asacol 800 mg (mesalamine)Drug
tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
Asacol 400 mg (mesalamine)Drug
tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Asacol 2.4 g/day | Active comparator | Asacol (2.4 g/day) Receives: Drug: Asacol 400 mg (mesalamine) |
| Asacol 4.8 g/day | Experimental | Asacol (4.8 g/day) Receives: Drug: Asacol 800 mg (mesalamine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)
Measured: 6 Weeks
Secondary outcomes (11)
Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population
UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]
Measured: 6 weeks
Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population
Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 0=normal (intact vascular pattern, no friability or granularity), 1=mild (erythema, diminished or absent vascular markings; mild granularity; friability), 2=moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations) 3=severe (spontaneous bleeding, ulcerations)
Measured: 6 Weeks
Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population
Sigmoidoscopy Assessment Score (0=normal intact vascular pattern, no friability or granularity, 1=mild erythema; diminished or absent vascular markings; mild granularity; friability, 2=moderate marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations, 3=severe spontaneous bleeding, ulcerations)
Measured: 6 Weeks
Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6
0=Normal stool frequency per day, 1=1-2 stools greater than normal per day, 2=3-4 stools greater than normal per day, 3=5 or more stools greater than normal per day
Measured: 6 Weeks
Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6
Rectal Bleeding (0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed)
Measured: 6 Weeks
Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6
PFA - 0=generally well, 1=fair, 2=poor, 3=terrible
Measured: 6 Weeks
Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6
PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA \& sigmoidoscopy findings] If scoring equal default to physician judgement.
Measured: 6 Weeks
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients
IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better.
Measured: 3 Weeks
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients
IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better.
Measured: 6 Weeks
Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients
Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)
Measured: 6 Weeks
Percentage of Treatment Success Patients at Week 3, ITT Population
Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2003 (estimated)
- Study startSep 2000
- Primary completionSep 2003
- Study completionSep 2003
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piotr Krzeski, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073021
- Sponsor's protocol ID
- 2000082
- Status last verified
- Jun 2015
- First submitted
- 13 Nov 2003
- Last updated
- 29 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther. 2011 May;33(9):1028-35. doi: 10.1111/j.1365-2036.2011.04620.x. Epub 2011 Mar 8.
PubMed 21385195Lichtenstein GR, Ramsey D, Rubin DT. Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4 g/day in endoscopic mucosal healing--ASCEND I and II combined analysis. Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi: 10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23.
PubMed 21255059
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00073021
- Acronym / sponsor ID
- 2000082
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 17 Nov 2003 (estimated)
- Results
- Posted 28 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asacol 2.4 g/day | Active comparator | Drug: Asacol 400 mg (mesalamine)Asacol (2.4 g/day) |
| Asacol 4.8 g/day | Experimental | Drug: Asacol 800 mg (mesalamine)Asacol (4.8 g/day) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female between 18 and 75 years of age;
- have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
- currently demonstrating moderately active disease
Key exclusion criteria (13 listed)
- a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- a history of extensive small bowel resection (>1/2 the length of the small intestine) causing short bowel syndrome;
- current renal or hepatic disease;
- participated in any drug or device clinical study within 30 days of entry;
- currently enrolled in any other clinical study;
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 |
|---|---|---|
| Asacol 800 mg (mesalamine)tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily | Drug | Asacol 4.8 g/day |
| Asacol 400 mg (mesalamine)tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily | Drug | Asacol 2.4 g/day |
Primary outcome
Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
Time frame: 6 Weeks
Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)
11 secondary outcomes
Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population
Time frame: 6 weeks
Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population
Time frame: 6 Weeks
Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population
Time frame: 6 Weeks
Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6
Time frame: 6 Weeks
Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6
Time frame: 6 Weeks
Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6
Time frame: 6 Weeks
Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6
Time frame: 6 Weeks
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients
Time frame: 3 Weeks
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients
Time frame: 6 Weeks
Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients
Time frame: 6 Weeks
Percentage of Treatment Success Patients at Week 3, ITT Population
Time frame: 3 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21385195Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther. 2011 May;33(9):1028-35. doi: 10.1111/j.1365-2036.2011.04620.x. Epub 2011 Mar 8.
- Derived from this study: PubMed 21255059Lichtenstein GR, Ramsey D, Rubin DT. Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4 g/day in endoscopic mucosal healing--ASCEND I and II combined analysis. Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi: 10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23.
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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.
Piotr Krzeski, MD study director
Procter and Gamble
57 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Asacol 800 mg (mesalamine) and Asacol 400 mg (mesalamine) in people with Ulcerative Colitis, run by Warner Chilcott at 57 sites in 3 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Canada, Puerto Rico. 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. 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 28 Jul 2011). 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 Treatment Success Patients at Week 6, ITT (Intent to Treat) Population (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00073021, which also lists 2 linked publications.
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 29 Jun 2015.