Ulcerative ColitisPhase 3NCT00350415
A Double Blind Study for the Treatment of Acute Ulcerative Colitis
A Phase 3 study testing Mesalamine in people with Ulcerative Colitis, run by Warner Chilcott at 135 sites in 15 countries.
Trial summary
A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III). 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?
- Mesalamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- 135 sitesin 15 countries
- Study dates
- Jun 2006to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
- Female patients need to be postmenopausal or using adequate contraception.
Who cannot join
- Patients with isolated proctitis
- Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.
Trial locations and contacts
135 sites in 15 countries.
135 sites in 15 countries
United States78 sites
Research Facility
Akron, Ohio, 44302
Research Facility
Alabaster, Alabama, 35007
Research Facility
Anaheim, California, 92801
Research Facility
Arlington Heights, Illinois, 60005
Research Facility
Atlanta, Georgia, 30033
Research Facility
Austin, Texas, 78743
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Baltimore, Maryland, 21215
Research Facility
Baton Rouge, Louisiana, 70809
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Beaver Falls, Pennsylvania, 15010
Research Facility
Binghamton, New York, 13903
Research Facility
Birmingham, Alabama, 35209
Research Facility
Bismarck, North Dakota, 58501-1640
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Boston, Massachusetts, 02115
Research Facility
Burbank, California, 91505
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Burlington, Vermont, 05401
Research Facility
Charlotte, North Carolina, 28262
Research Facility
Chesapeake, Virginia, 23320
Research Facility
Chevy Chase, Maryland, 20815
Research Facility
Chicago, Illinois, 60637
Research Facility
Cincinnati, Ohio, 45242
Research Facility
Columbia, Michigan, 65212
Research Facility
Columbia, South Carolina, 29203
Research Facility
Dayton, Ohio, 45440
Research Facility
DeLand, Florida, 32720
Research Facility
Egg Harbor, New Jersey, 08234
Research Facility
Encinitas, California, 93024
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Fargo, North Dakota, 58104
Research Facility
Fayetteville, Arkansas, 72703
Research Facility
Garden City, New York, 11530
Research Facility
Great Neck, New York, 11021
Research Facility
Hamden, Connecticut, 06518-3691
Research Facility
Harbor Village, Florida, 34684
Research Facility
Hollywood, Florida, 33021
Research Facility
Huntington, New York, 11743
Research Facility
Jacksonville, Florida, 32256
Research Facility
Kansas City, Missouri, 64131
Research Facility
Kingsport, Tennessee, 37660
Research Facility
Lakewood, Colorado, 80215
Research Facility
Little Rock, Arkansas, 72205
Research Facility
Littleton, Colorado, 80120
Research Facility
Los Angeles, California, 90067
Research Facility
Los Angeles, California, 90274
Research Facility
Louisville, Kentucky, 40292
Research Facility
Memphis, Tennessee, 38120
Research Facility
Milwaukee, Wisconsin, 53215
Research Facility
Minneapolis, Minnesota, 55455
Research Facility
Mission Hills, California, 91345
Research Facility
Murray, Utah, 84107
Research Facility
Nashville, Tennessee, 37232
Research Facility
New York, New York, 10021
Research Facility
Ogden, Utah, 84405
Research Facility
Omaha, Nebraska, 68131
Research Facility
Orange, California, 92868
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Panama City, Florida, 33405
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Pasadena, California, 91105
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Philadelphia, Pennsylvania, 19107
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Portland, Oregon, 97220
Research Facility
Redmond, Washington, 98052
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Reisterstown, Maryland, 21136
Research Facility
Rochester, Minnesota, 55905
Research Facility
Rochester, New York, 14642
Research Facility
Roseville, California, 95661
Research Facility
Sacramento, California, 95825
Research Facility
San Antonio, Texas, 78205
Research Facility
San Carlos, California, 94070
Research Facility
San Francisco, California, 94115
Research Facility
Savannah, Georgia, 31405
Research Facility
Scottsbluff, Nebraska, 69361
Research Facility
Shreveport, Louisiana, 71103
Research Facility
St Louis, Missouri, 63128
Research Facility
Topeka, Kansas, 60606
Research Facility
Troy, New York, 12180
Research Facility
Tucson, Arizona, 85712
Research Facility
Tupelo, Mississippi, 38801
Research Facility
Warren, Ohio, 44484
Research Facility
Wilmington, North Carolina, 28401
Research Facility
York, Pennsylvania, 17403
Research Facility
Zephyrhills, Florida, 33542
Canada15 sites
Research Facility
Abbotsford British Columbia, British Columbia, V2S 3N5
Research Facility
Edmonton, Alberta, T6G 2X8
Research Facility
Guelph, Ontario, N1H 3R3
Research Facility
Hamilton, Ontario, L8N 3Z5
Research Facility
Lévis, Quebec, G6V 3Z1
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London, Ontario, N6A 5K8
Research Facility
Longheuil, Quebec, J4N 1E1
Research Facility
Montreal, Quebec, H31 1E2
Research Facility
Ottawa, Ontario, K1H 8L6
Research Facility
Québec, Quebec, G1L 3L5
Research Facility
Québec, Quebec, G1R 2J6
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Rimouski, Quebec, G5L 5T1
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Saskatoon, Saskatchewan, S7K 1N4
Research Facility
Toronto, Ontario, M3N 2V7
Research Facility
Vancouver, British Columbia, V5Z 112
Poland8 sites
Research Facility
Bydgoszcz, Bydgoszcz, 85-681
Research Facility
Częstochowa, Czestochowa, 42-200
Research Facility
Krakow, Krakow, 31-501
Research Facility
Lodz, Łódź Voivodeship, 90-153
Research Facility
Pruszków, Pruszkow, 05-800
Research Facility
Sopot, Sopot, 81-756
Research Facility
Warsaw, Warszawa, 02-57
Research Facility
Wtoctawek, Wtoctawek, 87-800
Czechia5 sites
Research Facility
Kralove, Kralove, 500 12
Research Facility
Pavlov, Pavlov
Research Facility
Prague, Praha 2, 120 00
Research Facility
Strakonice, Strakonice, 3886 29
Research Facility
Ústí nad Labem, Usti nad Labem, 401 13
Ukraine5 sites
Research Facility
Kharkiv, Kharkiv Oblast, 61037
Research Facility
Kyiv, Kyiv Oblast, 04053
Research Facility
Simpheropol, Simpheropol, 95000
Research Facility
Zabolotnogo, Odesa Oblast, 65025
Research Facility
Zaporizhzhya, Zaporizhzhya, 69050
Belarus4 sites
Research Facility
Gornel, Gormel
Research Facility
Hrodna, Grodnenskaya, 230017
Research Facility
Minsk, Minsk City, 220013
Research Facility
Vitebsk, Vitebsk Oblast, 210037
Hungary3 sites
Research Facility
Argenti Dome Ter, Argenti Dome Ter, 1-3
Research Facility
Budapest, Budapest
Research Facility
Nagyerdei Krt, Nagyerdei Krt, 98
Lithuania3 sites
Research Facility
Kaunas, Kaunas County, LT-50009
Research FacilityPanevezys
Panevezys, Panevėžys, LT-35144
Research Facility
Santariskiu, Vilnius County, LT-08661
Romania3 sites
Research Facility
Bucharest, Bucharest, 010825
Research Facility
Cluj-Napoca, Cluj-napoca, 400162
Research Facility
Iași, Iaşi, 700111
Russia3 sites
Research Facility
Moscow, Mowcow, 129110
Research Facility
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126
Research Facility
Saint Petersburg, Sankt-Peterburg, 196247
Croatia2 sites
Research Facility
Rijeka, Rijeka, 51000
Research Facility
Zagreb, City of Zagreb, 10000
Estonia2 sites
Research Facility
Tallinn, Tallinn, 10138
Research Facility
Tartu, Tartu, 51014
Serbia2 sites
Research Facility
Belgrade, Beograd, 11080
Research Facility
Novi Sad, Novi Sad, 21000
About this study
Official title: A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.
A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).
Read the detailed description
This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.
- Conditions
- Ulcerative Colitis
- Being tested
- Mesalamine
- Keywords
- ulcerative colitis, inflammatory bowel disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
Asacol 400g/day (400 mg tablet), oral, for 6 weeks
OR
Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Asacol 2.4 g/day (400 mg tablet) Receives: Drug: Mesalamine |
| 2 | Active comparator | Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks Receives: Drug: Mesalamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
Measured: Week 6
Secondary outcomes (1)
Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3.
Measured: week 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 772 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
- NCT00350415
- Sponsor's protocol ID
- 2006444
- Status last verified
- Apr 2013
- First submitted
- 6 Jul 2006
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. 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 the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT00350415
- Acronym / sponsor ID
- 2006444
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, inflammatory bowel disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 772 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).
Detailed description
This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MesalamineAsacol 2.4 g/day (400 mg tablet) |
| 2 | Active comparator | Drug: MesalamineAsacol 4,8 g/day (800 mg tablet), oral, for 6 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
- Female patients need to be postmenopausal or using adequate contraception.
Key exclusion criteria (2 listed)
- Patients with isolated proctitis
- Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.
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 |
|---|---|---|
| MesalamineAsacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks | Drug | 1, 2 |
Primary outcome
Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
Time frame: Week 6
1 secondary outcome
Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3.
Time frame: week 3 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- Related InfoLink provided by the sponsor.
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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
135 sites in 15 countries: 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 135 sites in 15 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 2 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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 135 sites in United States, Canada, Poland, Czechia, Ukraine and 10 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6. (time frame: Week 6). 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 17 Apr 2013.