Ulcerative ColitisPhase 3CAMPIIINCT01004185
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
A Phase 3 study testing Asacol 400 mg in people with Ulcerative Colitis, run by Warner Chilcott at 51 sites in 6 countries.
Trial summary
The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of 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
- 39 participants
- Where
- 51 sitesin 6 countries
- Study dates
- Oct 2009to 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
- male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication;
- have a documented history of UC that has been successfully maintained in complete remission for at least 1 month prior to study entry
- have a baseline PUCAI score < 10
- have a body weight no less than 17 kg and no more than 90 kg
- have a history of at least 1 active episode or relapse in the last 12 months
- have taken a stable maintenance dose of oral mesalamine (or equivalent oral 5-ASA dose) for at least 1 month prior to entry in the study. Stable is defined as the same dose for the last month.
- maintained complete remission, as defined, throughout the 30-day run-in phase. Note:ONLY applies to those patients who complete the 6-week treatment in complete remission from Study 2007017 and immediately roll-over to the 30-day run-in phase
- are female patients who are pre-menarchal or have a negative urine pregnancy test and, if sexually active, practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]
Who cannot join
- 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
- have a history or presence of any condition causing malabsorption or an effect on gastrointestinal motility or history of extensive small bowel resection (greater than one half the length of the small intestine) causing short bowel syndrome
- any "condition" causing "malabsorption" or an effect on gastrointestinal "motility"
- have current renal disease, or a screening blood urea nitrogen (BUN) or creatinine value that is > 1.5 times the upper limit of the age appropriate normal
- have a documented history of or current hepatic disease, or liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], total bilirubin) that are > 2 times the upper limit of normal
Show all 15Show fewer
- have a history of pancreatitis
- have undergone treatment with any oral, intravenous, intramuscular, or rectally administered corticosteroids (including budesonide) within 30 days prior to the Screening visit
- have undergone treatment with any rectal mesalamine therapy within 30 days prior to the screening visit
- have undergone treatment with immunomodulatory therapy including, but not limited to: rosiglitazone, 6-mercaptopurine or azathioprine, cyclosporine, or methotrexate within 90 days prior to Screening visit
- have undergone treatment with biologic therapy including, but not limited to: infliximab,adalimumab, certolizumab or other biologic treatment of ulcerative colitis within 90 days prior to Screening visit
- have undergone treatment with antibiotics (other than topical antibiotics) including metronidazole within 7 days prior to the Screening visit
- have undergone treatment with aspirin or other nonsteroidal anti-inflammatory drugs NSAIDs) within 7 days prior to the Screening visit
- have undergone treatment with any antidiarrheals and/or antispasmodics within 30 days of the Screening visit
- have a stool examination positive for Clostridium difficile (C. difficile), bacterial pathogens, or ova and parasites. Note: Because normal gut flora may vary by geography, the Medical Monitor should be consulted before excluding a patient with a stool sample that is positive for C. difficile, bacterial pathogens or ova and parasites.
Trial locations and contacts
51 sites in 6 countries.
51 sites in 6 countries
United States25 sites
Research Site
Birmingham, Alabama, 35233
Research Site
Boston, Massachusetts, 02114
Research Site
Buffalo, New York, 14222
Research Site
Fort Worth, Texas, 76104
Research Site
Gainesville, Florida, 32601
Research Site
Huntington, West Virginia, 25701
Research Site
Jackson, Mississippi, 39202
Research Site
Kansas City, Missouri, 64108
Research Site
Las Vegas, Nevada, 89109
Research Site
Loma Linda, California, 92354
Research Site
Louisville, Kentucky, 40202
Research Site
Mays Landing, New Jersey, 08330
Research Site
Miami, Florida, 33155
Research Site
Nashville, Tennessee, 37232
Research Site
New Hyde Park, New York, 11040
Research Site
Park Ridge, Illinois, 60068
Research Site
Phoenix, Arizona, 85016
Research Site
Portland, Maine, 04102
Research Site
Providence, Rhode Island, 02903
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92123
Research Site
San Francisco, California, 94118
Research Site
San Francisco, California, 94143
Research Site
Southfield, Michigan, 48075
Research Site
Worcester, Massachusetts, 01655
Russia9 sites
Research Site
Kazan', 420138
Research Site
Moscow, 103001
Research Site
Moscow, 105077
Research Site
Moscow, 117963
Research Site
Moscow, 119021
Research Site
Moscow, 127412
Research Site
Nizhny Novgorod, 603950
Research Site
Novosibirsk, 630091
Research Site
Smolensk, 214019
Poland7 sites
Research Site
Bialystok, 15-274
Research Site
Bydgoszcz, 85-094
Research Site
Katowice, 40-752
Research Site
Krakow, 30-663
Research Site
Lodz, 91-738
Research Site
Warsaw, 04-730
Research Site
Wroclaw, 50-369
Canada5 sites
Research Site
Edmonton, Alberta, T6G 2J3
Research Site
Halifax, Nova Scotia, B3K 6R8
Research Site
Hamilton, Ontario, L8N 3Z5
Research Site
London, Ontario, N6A 5W9
Research Site
Ottawa, Ontario, K1H 8L1
Romania3 sites
Research Site
Bucharest, 00 17 43
Research Site
Bucharest, 04 14 51
Research Site
Iași, 70 03 09
About this study
Official title: A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of 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
Also called mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine
17-33kg = 3 Asacol 400mg AM \& 2 Asacol 400mg PM; 33-<54kg = 5 Asacol 400 mg AM \& 4 Asacol 400mg PM; 54-<90kg = 6 Asacol 400mg AM \& PM
Asacol 400 mgDrug
Also called mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine
17-<33kg = 2 Asacol 400mg \& 1 placebo AM, 1 Asacol 400mg \& 1 placebo PM; 33-<54kg = 3 Asacol 400mg \& 2 placebo AM, 2 Asacol 400mg \& 2 placebo PM; 54-<90kg = 3 Asacol 400mg \& 3 placebo AM \& PM
| Study group | Role | What they receive |
|---|---|---|
| High Dose | Experimental | 2.0 - 4.8 g/day Asacol dependent on body weight Receives: Drug: Asacol 400 mg |
| Low Dose | Experimental | 1.2 - 2.4 g/day Asacol dependent upon 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 Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.
Measured: Week 26
Secondary outcomes (1)
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
PUCAI Score (0-85, sum of scores for each) abdominal pain (0/2.5/5/7.5/10 - no pain/very mild/mild/moderate/severe), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission is Treatment Success.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Pediatric enrollment very slow.
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herman Ellman, MD, Study director, Warner Chilcott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004185
- Sponsor's protocol ID
- 2008085
- Acronym
- CAMPIII
- Status last verified
- Apr 2012
- First submitted
- 27 Oct 2009
- Last updated
- 25 May 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 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01004185
- Acronym / sponsor ID
- CAMPIII / 2008085
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pediatric enrollment very slow.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Posted 25 May 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 study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose | Experimental | Drug: Asacol 400 mg2.0 - 4.8 g/day Asacol dependent on body weight |
| Low Dose | Experimental | Drug: Asacol 400 mg1.2 - 2.4 g/day Asacol dependent upon body weight |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication;
- have a documented history of UC that has been successfully maintained in complete remission for at least 1 month prior to study entry
- have a baseline PUCAI score < 10
- have a body weight no less than 17 kg and no more than 90 kg
- have a history of at least 1 active episode or relapse in the last 12 months
Key exclusion criteria (15 listed)
- 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
- have a history or presence of any condition causing malabsorption or an effect on gastrointestinal motility or history of extensive small bowel resection (greater than one half the length of the small intestine) causing short bowel syndrome
- any "condition" causing "malabsorption" or an effect on gastrointestinal "motility"
- have current renal disease, or a screening blood urea nitrogen (BUN) or creatinine value that is > 1.5 times the upper limit of the age appropriate normal
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 mgAlso: mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine17-33kg = 3 Asacol 400mg AM \& 2 Asacol 400mg PM; 33-<54kg = 5 Asacol 400 mg AM \& 4 Asacol 400mg PM; 54-<90kg = 6 Asacol 400mg AM \& PM | Drug | High Dose |
| Asacol 400 mgAlso: mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine17-<33kg = 2 Asacol 400mg \& 1 placebo AM, 1 Asacol 400mg \& 1 placebo PM; 33-<54kg = 3 Asacol 400mg \& 2 placebo AM, 2 Asacol 400mg \& 2 placebo PM; 54-<90kg = 3 Asacol 400mg \& 3 placebo AM \& PM | Drug | Low Dose |
Primary outcome
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
Time frame: Week 26
PUCAI Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.
1 secondary outcome
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
Time frame: Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 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.
Herman Ellman, MD study director
Warner Chilcott
51 sites in 6 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 51 sites in 6 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 8 inclusion and 15 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 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Russia, Poland, Canada, Romania and 1 more country. 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 25 May 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: Week 26). 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 25 May 2012.