Ulcerative ColitisPhase 3NCT00713310
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
A Phase 3 study testing Asacol 400 mg in people with Ulcerative Colitis, run by Warner Chilcott at 42 sites in 5 countries.
Trial summary
The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Asacol 400 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 42 sitesin 5 countries
- Study dates
- Dec 2008to Mar 2011
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- are male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication, with a history of biopsy and endoscopy confirmed UC;
- have mildly-to-moderately active UC (either newly diagnosed or that has relapsed) as defined clinically by a Pediatric UC Activity Index (PUCAI) score 10 and 55, and, in the opinion of the Investigator, the patient does not require steroids;
- have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with stool less than half of the time) and stool frequency (1-2 stools greater than normal per day) as defined by the TM-Mayo Score
Who cannot join
- have UC known to be confined to the rectum (isolated rectal proctitis);
- have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Asacol tablet;
- have a significant co-existing illness or other condition(s), including but not limited to cancer or significant organic or psychiatric disease on medical history or physical examination, that, in the judgment of the Investigator, contraindicate(s) administration of the study drug and/or any study procedures
Trial locations and contacts
42 sites in 5 countries.
42 sites in 5 countries
United States26 sites
Research Facility
Birmingham, Alabama, 35233
Research Facility
Boston, Massachusetts, 02114
Research Facility
Buffalo, New York, 14222
Research Facility
Chattanooga, Tennessee, 37404
Research Facility
Fort Worth, Texas, 76104
Research Facility
Gainesville, Florida, 32610
Research Facility
Houston, Texas, 77030
Research Facility
Huntington, West Virginia, 25701
Research Facility
Kansas City, Missouri, 64108
Research Facility
Knoxville, Tennessee, 37916
Research Facility
Loma Linda, California, 92354
Research Facility
Louisville, Kentucky, 40202
Research Facility
Mays Landing, New Jersey, 08330
Research Facility
New Hyde Park, New York, 11040
Research Facility
Norfolk, Virginia, 23507
Research Facility
Omaha, Nebraska, 68015
Research Facility
Park Ridge, Illinois, 60068
Research Facility
Phoenix, Arizona, 85016
Research Facility
Portland, Oregon, 97239-3098
Research Facility
San Antonio, Texas, 78229
Research Facility
San Diego, California, 92123
Research Facility
San Francisco, California, 94118
Research Facility
San Francisco, California, 94143
Research Facility
Washington D.C., District of Columbia, 20010
Research Facility
Worcester, Massachusetts, 01655
Research Facility
Youngstown, Ohio, 44514
Poland6 sites
Research Site
Bialystok, Poland, 15-274
Research Site
Bydgoszcz, Poland, 85-094
Research Site
Krakow, Poland, 30-663
Research Site
Lodz, Poland, 91-738
Research Site
Warsazawa, Poland, 04-730
Research Site
Wroclaw, Poland, 50-369
Canada5 sites
Research Facility
Halifax, Nova Scotia, B3K 6R8
Research Facility
Hamilton, Ontario, L8N 3Z5
Research Facility
London, Ontario, N6A 5W9
Research Facility
Montreal, Quebec, H3T 1C5
Research Facility
Ottawa, Ontario, K1H 8L1
Romania3 sites
Research Site
Bucharest, Romania, 011743
Research Site
Bucharest, Romania, 041451
Research Site
Iași, Romania, 700309
Croatia2 sites
Research Site
Rijeka, Croatia, 51000
Research Site
Zagreb, Croatia, 10000
About this study
Official title: Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis
The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Asacol 400 mg
- 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 400 mgDrug
High dose:
17-<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM
Asacol 400 mgDrug
Low dose:
17-<33 kg = 2 Asacol 400mg + 1 placebo in morning and 1 Asacol 400 +1 placebo in PM, 33-<54 kg = 3 Asacol 400mg +2 placebo in morning and 2 Asacol 400 + 2 placebo in PM, 54-<90 kg = 3 Asacol 400mg + 3 placebo in morning and 3 Asacol 400mg + 3 placebo in PM
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose | Experimental | 1.2 - 2.4 g/day Asacol dependent on body weight Receives: Drug: Asacol 400 mg |
| High-Dose | Experimental | 2.0 - 4.8 g/day Asacol dependent on body weight Receives: Drug: Asacol 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2011
- Study completionMar 2011
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 (1)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Preston M Dunnmon, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713310
- Sponsor's protocol ID
- 2007017
- Status last verified
- Apr 2012
- First submitted
- 9 Jul 2008
- Last updated
- 5 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Winter HS, Krzeski P, Heyman MB, Ibarguen-Secchia E, Iwanczak B, Kaczmarski M, Kierkus J, Kolacek S, Osuntokun B, Quiros JA, Shah M, Yacyshyn B, Dunnmon PM. High- and low-dose oral delayed-release mesalamine in children with mild-to-moderately active ulcerative colitis. J Pediatr Gastroenterol Nutr. 2014 Dec;59(6):767-72. doi: 10.1097/MPG.0000000000000530.
PubMed 25419597
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00713310
- Acronym / sponsor ID
- 2007017
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Posted 4 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose | Experimental | Drug: Asacol 400 mg1.2 - 2.4 g/day Asacol dependent on body weight |
| High-Dose | Experimental | Drug: Asacol 400 mg2.0 - 4.8 g/day Asacol dependent on body weight |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- are male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication, with a history of biopsy and endoscopy confirmed UC;
- have mildly-to-moderately active UC (either newly diagnosed or that has relapsed) as defined clinically by a Pediatric UC Activity Index (PUCAI) score 10 and 55, and, in the opinion of the Investigator, the patient does not require steroids;
- have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with stool less than half of the time) and stool frequency (1-2 stools greater than normal per day) as defined by the TM-Mayo Score
Key exclusion criteria (3 listed)
- have UC known to be confined to the rectum (isolated rectal proctitis);
- have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Asacol tablet;
- have a significant co-existing illness or other condition(s), including but not limited to cancer or significant organic or psychiatric disease on medical history or physical examination, that, in the judgment of the Investigator, contraindicate(s) administration of the study drug and/or any study procedures
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 400 mgHigh dose: 17-<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM | Drug | High-Dose |
| Asacol 400 mgLow dose: 17-<33 kg = 2 Asacol 400mg + 1 placebo in morning and 1 Asacol 400 +1 placebo in PM, 33-<54 kg = 3 Asacol 400mg +2 placebo in morning and 2 Asacol 400 + 2 placebo in PM, 54-<90 kg = 3 Asacol 400mg + 3 placebo in morning and 3 Asacol 400mg + 3 placebo in PM | Drug | Low-Dose |
Primary outcome
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
Time frame: Baseline and 6 weeks
PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)
1 secondary outcome
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25419597Winter HS, Krzeski P, Heyman MB, Ibarguen-Secchia E, Iwanczak B, Kaczmarski M, Kierkus J, Kolacek S, Osuntokun B, Quiros JA, Shah M, Yacyshyn B, Dunnmon PM. High- and low-dose oral delayed-release mesalamine in children with mild-to-moderately active ulcerative colitis. J Pediatr Gastroenterol Nutr. 2014 Dec;59(6):767-72. doi: 10.1097/MPG.0000000000000530.
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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.
Preston M Dunnmon, MD study director
Procter and Gamble
42 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Asacol 400 mg in people with Ulcerative Colitis, run by Warner Chilcott at 42 sites in 5 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 3 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 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Poland, Canada, Romania, Croatia. 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 4 Apr 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?
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population (time frame: Baseline and 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 NCT00713310, which also lists 1 linked publication.
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 5 Apr 2012.