Ulcerative ColitisPhase 3ASCEND INCT00577473

Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

A Phase 3 study testing mesalamine in people with Ulcerative Colitis, run by Warner Chilcott at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: mesalamine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 301 participants
Where: 44 sitesUnited States
Study dates: Feb 2001to Feb 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

confirmed diagnosis of ulcerative colitis

Who cannot join

a history of allergy or hypersensitivity to salicylates or aminosalicylates;
a history of extensive small bowel resection

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

Research Site
Anaheim, California
Research Site
Arlington Heights, Illinois
Research Facility
Atlanta, Georgia
Research Site
Baltimore, Maryland
Research Site
Birmingham, Alabama
Research Site
Bridgeport, Connecticut
Research Site
Burlington, Vermont
Research Site
Charleston, South Carolina
Research Site
Charlottesville, Virginia
Research Site
Cincinnati, Ohio
Research Facility
Decatur, Georgia
Research Site
Denver, Colorado
Research Site
Detroit, Michigan
Research Facility
Falls Church, Virginia
Research Site
Fort Myers, Florida
Research Site
Fort Worth, Texas
Research Facility
Golden, Colorado
Research Site
Great Neck, New York
Research Site
Hollywood, Florida
Research Site
Houston, Texas
Research Site
Jupiter, Florida
Research Site
Laurel, Maryland
Research Facility
Memphis, Tennessee
Research Site
Metairie, Louisiana
Research Site
Miami, Florida
Research Site
Milwaukee, Wisconsin
Research Site
Moline, Illinois
Research Facility
Nashville, Tennessee
Research Site
New Brunswick, New Jersey
Research Site
Norfolk, Virginia
Research Site
Philadelphia, Pennsylvania
Research Site
Pittsburgh, Pennsylvania
Research Site
Pomona, New York
Research Facility
Poughkeepsie, New York
Research Site
Raleigh, North Carolina
Research Site
Rockford, Illinois
Research Site
Sacramento, California
Research Site
San Antonio, Texas
Research Site
San Francisco, California
Research Site
Somerville, New Jersey
Research Site
Tacoma, Washington
Research Site
Tulsa, Oklahoma
Research Site
Wichita, Kansas
Research Site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day

The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

Read the detailed description

This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Conditions: Ulcerative Colitis
Being tested: 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.

mesalamineDrug
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
mesalamineDrug
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Study groups in NCT00577473
Study group	Role	What they receive
1	Active comparator	mesalamine 2.4 g/day (400 mg tablet) for 6 weeks Receives: Drug: mesalamine
2	Experimental	mesalamine 4.8 g/day (800 mg tablet) for 6 weeks Receives: Drug: mesalamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.
Measured: 6 weeks

Secondary outcomes (11)

Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.
Measured: 3 weeks
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.
Measured: Week 3
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.
Measured: Week 6
Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
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, Scoring Scale: 0-good thru 3-worse.
Measured: Week 3
Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
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, Scoring Scale: 0-good thru 3-worse.
Measured: Week 6
Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
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, Scoring Scale: 0-good thru 3-worse.
Measured: Week 3
Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
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. Scoring Scale: 0-good thru 3-worse.
Measured: Week 6
Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
0-generally well, 1-fair, 2-poor, 3-terrible
Measured: Week 3
Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
0-generally well, 1-fair, 2-poor, 3-terrible
Measured: Week 6
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
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). Scoring Scale: 0-good thru 3-worse.
Measured: Week 3
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
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). Scoring Scale: 0-good thru 3-worse.
Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2001Feb 2003

First posted20 Dec 2007 (estimated)
Study startFeb 2001
Primary completionFeb 2003
Study completionFeb 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: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00577473
Sponsor's protocol ID: 2000083
Acronym: ASCEND I
Status last verified: Sep 2011
First submitted: 19 Dec 2007
Last updated: 16 Sep 2011
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 21385195
Lichtenstein 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2011. 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 in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day
ClinicalTrials.gov ID: NCT00577473
Acronym / sponsor ID: ASCEND I / 2000083
Conditions: Ulcerative Colitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: Feb 2001
Primary completion: Feb 2003 (actual)
Study completion: Feb 2003 (actual)
First posted: 20 Dec 2007 (estimated)
Results: Posted 22 Jun 2011

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 study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: mesalaminemesalamine 2.4 g/day (400 mg tablet) for 6 weeks
2	Experimental	Drug: mesalaminemesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

confirmed diagnosis of ulcerative colitis

Key exclusion criteria (2 listed)

a history of allergy or hypersensitivity to salicylates or aminosalicylates;
a history of extensive small bowel resection

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
mesalaminemesalamine 2.4 g/day (400 mg tablet) for 6 weeks	Drug	1
mesalaminemesalamine 4.8 g/day (800 mg tablet) for 6 weeks	Drug	2

Primary outcome

Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
Time frame: 6 weeks
Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.

11 secondary outcomes

Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
Time frame: 3 weeks
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
Time frame: Week 3
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
Time frame: Week 6
Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
Time frame: Week 3
Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
Time frame: Week 6
Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
Time frame: Week 3
Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
Time frame: Week 6
Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
Time frame: Week 3
Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
Time frame: Week 6
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
Time frame: Week 3
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
Time frame: Week 6

Results and safety

Results posted to the registry on 22 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Asacol 2.4 g/Day	154	133
Asacol 4.8 g/Day	147	123

Primary outcome: Percentage of Patients Classified as Treatment Success at Week 6, ITT Population

Time frame: 6 weeks. Number. Unit: Percentage of Participants

Measure	Asacol 2.4 g/Day n = 150	Asacol 4.8 g/Day n = 136
Value	51.3	55.9

Asacol 2.4 g/Day vs Asacol 4.8 g/Day: Risk Difference (RD): 0.0455 (95% CI -7.01 to 16.11), p = 0.4411, Chi-squared

Population analysed: ITT Population

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 week treatment period. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Asacol 2.4 g/Day	3 of 154 (1.9%)	56 of 154 (36.4%)	Not reported
Asacol 4.8 g/Day	1 of 147 (0.7%)	48 of 147 (32.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
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.

Jeffery Kralstein, MD study director

Procter and Gamble

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mesalamine in people with Ulcerative Colitis, run by Warner Chilcott at 44 sites in United States.

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 1 inclusion and 2 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 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. 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 22 Jun 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 Patients Classified as Treatment Success at Week 6, ITT 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 NCT00577473, 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 16 Sep 2011.