CompletedNCT00713310Updated Apr 5, 2012Results posted

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

A Phase 3 interventional study of Asacol 400 mg and Asacol 400 mg in Ulcerative Colitis, sponsored by Warner Chilcott. Completed at 42 sites in 5 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2012-04-05.

Sponsored by Warner Chilcott · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 83
Allocation: Randomized
Ages: 5 Years to 17 Years
Sex: All

Study 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.

Conditions studied

Ulcerative Colitis

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In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 83 is above the median of 60 across 771 interventional studies indexed under Colitis.

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Lead sponsor

Warner Chilcott is the lead sponsor of 57 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 5 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 83 participants (actual)

Study arms

Experimental
Low-Dose
1.2 - 2.4 g/day Asacol dependent on body weight
Drug: Asacol 400 mg
Experimental
High-Dose
2.0 - 4.8 g/day Asacol dependent on body weight
Drug: Asacol 400 mg

Interventions

DrugAsacol 400 mg
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
DrugAsacol 400 mg
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

What researchers measure

Primary outcomes

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)
Time frame: Baseline and 6 weeks

Secondary outcomes

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)
Time frame: Baseline and Week 6

Results

Posted Apr 4, 2012

Participant flow

Recruitment began 16 Dec 2008

Participant flow — Overall Study
Milestone	Low-Dose	High-Dose
Started	41	42
Mitt population	41	41
Completed	36	36
Not completed	5	6
Withdrew: Adverse event	5	2
Withdrew: Lack of efficacy	0	2
Withdrew: Withdrawal by subject	0	2

Outcome measures

PrimaryTreatment 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)

Time frame:: Baseline and 6 weeks
Reported as:: Number · % participants with treatment success

Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
% participants with treatment success	Low Dose	High Dose
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population	56.1	55.0

Statistical analysis

Low Dose vs High Dose · Cochran-Mantel-Haenszel · p = 0.9240 · High-low dose difference success rates: -1.1 · 95% CI -22.7 to 20.5

SecondaryTreatment 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)

Time frame:: Baseline and Week 6
Reported as:: Number · % participants with treatment success

Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
% participants with treatment success	Low Dose	High Dose
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT	56.1	57.5

Statistical analysis

Low Dose vs High Dose · Cochran-Mantel-Haenszel · p = 0.8193 · High-low dose difference success rates: 1.4 · 95% CI -20.2 to 23.0

Adverse events

Collected over Day -7 thru Week 6 of trial (7 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Low Dose	—	5/41 (12.2%)	20/50 (40%)
High Dose	—	2/41 (4.9%)	15/41 (36.6%)

Most frequent serious events

Most frequent serious events
Event	Low Dose	High Dose
SinusitisInfections and infestations	1/41	0/41
Abdominal PainGastrointestinal disorders	1/41	0/41
Body Mass Index DecreasedInvestigations	1/41	0/41
Colitis UlcerativeGastrointestinal disorders	1/41	1/41
Adenovirus InfectionInfections and infestations	1/41	0/41
Diarrhoea HaemorrhagicGastrointestinal disorders	1/41	0/41
Cholangitis SclerosingHepatobiliary disorders	1/41	0/41
PancreatitisGastrointestinal disorders	1/41	0/41
AnaemiaBlood and lymphatic system disorders	0/41	1/41
SyncopeNervous system disorders	0/41	1/41

Most frequent other events

Most frequent other events
Event	Low Dose	High Dose
Colitis UlcerativeGastrointestinal disorders	5/50	2/41
NasopharyngitisInfections and infestations	4/50	4/41
HeadacheNervous system disorders	4/50	2/41
FatigueGeneral disorders	1/50	3/41
PyrexiaGeneral disorders	0/50	3/41
SinusitisInfections and infestations	3/50	0/41
DizzinessNervous system disorders	3/50	1/41

Baseline characteristics

Age Continuous
Age Continuous(years)	Low-Dose	High-Dose	Total
Mean	13.0 ± 3.2	12.8 ± 3.0	12.9 ± 3.1

Age, Customized
Age, Customized(participants)	Low-Dose	High-Dose	Total
5-8 years	4	4	8
9-17 years	37	38	75

Sex: Female, Male
Sex: Female, Male(Participants)	Low-Dose	High-Dose	Total
Female	22	23	45
Male	19	19	38

Region of Enrollment
Region of Enrollment(participants)	Low-Dose	High-Dose	Total
United States	26	23	49
Canada	0	4	4
Poland	9	10	19
Romania	2	3	5
Croatia	4	2	6

Study locations

42 sites

Research Facility
Birmingham, Alabama 35233, United States
Research Facility
Phoenix, Arizona 85016, United States
Research Facility
Loma Linda, California 92354, United States
Research Facility
San Diego, California 92123, United States
Research Facility
San Francisco, California 94118, United States
Research Facility
San Francisco, California 94143, United States
Research Facility
Washington, District of Columbia 20010, United States
Research Facility
Gainesville, Florida 32610, United States
Research Facility
Park Ridge, Illinois 60068, United States
Research Facility
Louisville, Kentucky 40202, United States
Research Facility
Boston, Massachusetts 02114, United States
Research Facility
Worcester, Massachusetts 01655, United States
Research Facility
Kansas City, Missouri 64108, United States
Research Facility
Omaha, Nebraska 68015, United States
Research Facility
Mays Landing, New Jersey 08330, United States
Research Facility
Buffalo, New York 14222, United States
Research Facility
New Hyde Park, New York 11040, United States
Research Facility
Youngstown, Ohio 44514, United States
Research Facility
Portland, Oregon 97239-3098, United States
Research Facility
Chattanooga, Tennessee 37404, United States
Research Facility
Knoxville, Tennessee 37916, United States
Research Facility
Fort Worth, Texas 76104, United States
Research Facility
Houston, Texas 77030, United States
Research Facility
San Antonio, Texas 78229, United States
Research Facility
Norfolk, Virginia 23507, United States
Research Facility
Huntington, West Virginia 25701, United States
Research Facility
Halifax, Nova Scotia B3K 6R8, Canada
Research Facility
Hamilton, Ontario L8N 3Z5, Canada
Research Facility
London, Ontario N6A 5W9, Canada
Research Facility
Ottawa, Ontario K1H 8L1, Canada
Research Facility
Montreal, Quebec H3T 1C5, Canada
Research Site
Rijeka, 51000, Croatia
Research Site
Zagreb, 10000, Croatia
Research Site
Bialystok, 15-274, Poland
Research Site
Bydgoszcz, 85-094, Poland
Research Site
Krakow, 30-663, Poland
Research Site
Lodz, 91-738, Poland
Research Site
Warsazawa, 04-730, Poland
Research Site
Wroclaw, 50-369, Poland
Research Site
Bucharest, 011743, Romania
Research Site
Bucharest, 041451, Romania
Research Site
Iasi, 700309, Romania

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00713310
Lead sponsor: Warner Chilcott
Responsible party: Sponsor
First posted: Jul 11, 2008
Start date: Dec 2008
Primary completion: Mar 2011
Completion: Mar 2011
Results posted: Apr 4, 2012
Last update: Apr 5, 2012

Study contacts

Preston M Dunnmon, MD

study director · Procter and Gamble

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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