Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

This study has been completed.

Study NCT00073021 Information provided by Warner Chilcott

First Received on November 13, 2003. Last Updated on September 14, 2011 History of Changes

Results First Received: March 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Ulcerative Colitis
Interventions:	Drug: Asacol 800 mg (mesalamine) Drug: Asacol 400 mg (mesalamine)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began Feb. 28, 2001. Randomized 386 patients of which 117 had mild disease and 268 had moderate disease at baseline. Analysis only includes patients with moderate disease at baseline.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Asacol 2.4 g/Day	Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Asacol 4.8 g/Day	Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).

Participant Flow: Overall Study

	Asacol 2.4 g/Day	Asacol 4.8 g/Day
STARTED	139 ^[1]	129 ^[1]
COMPLETED	113	113
NOT COMPLETED	26	16
Protocol Violation	2	1
Adverse Event	4	4
Withdrawal by Subject	6	5
Physician Decision	3	1
Lack of Efficacy	11	5

[1]	Subjects with Moderate Disease [PGA = 2] at Baseline

Baseline Characteristics

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Reporting Groups

	Description
Asacol 2.4 g/Day	Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Asacol 4.8 g/Day	Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).

Baseline Measures

	Asacol 2.4 g/Day	Asacol 4.8 g/Day	Total
Number of Participants [units: participants]	139	129	268
Age, Customized ^[1] [units: Participants]
18 - 64 years	126	118	244
>= 65 years	13	11	24
Gender ^[2] [units: participants]
Female	77	75	152
Male	62	54	116
Race/Ethnicity, Customized ^[2] [units: Participants]
Caucasian	108	96	204
Black or African American	11	14	25
Asian (Indian)	1	2	3
Asian (Oriental)	1	3	4
Hispanic	16	11	27
Multi-racial/other	2	3	5

[1]	All Randomized Patients with Moderate Disease [PGA (Physician's Global Assessment) = 2] at Baseline
[2]	All Randomized Patients with Moderate Disease [PGA = 2] at Baseline

Outcome Measures

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1. Primary:

Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population [ Time Frame: 6 Weeks ]

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2. Secondary:

Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population [ Time Frame: 6 weeks ]

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3. Secondary:

Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population [ Time Frame: 6 Weeks ]

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4. Secondary:

Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population [ Time Frame: 6 Weeks ]

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5. Secondary:

Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 [ Time Frame: 6 Weeks ]

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6. Secondary:

Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6 [ Time Frame: 6 Weeks ]

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7. Secondary:

Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6 [ Time Frame: 6 Weeks ]

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8. Secondary:

Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6 [ Time Frame: 6 Weeks ]

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9. Secondary:

Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients [ Time Frame: 3 Weeks ]

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10. Secondary:

Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients [ Time Frame: 6 Weeks ]

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11. Secondary:

Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients [ Time Frame: 6 Weeks ]

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12. Secondary:

Percentage of Treatment Success Patients at Week 3, ITT Population [ Time Frame: 3 Weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
phone: 973-442-3376
e-mail: gwulff@wcrx.com

No publications provided by Warner Chilcott

Publications automatically indexed to this study:

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. Epub 2011 Mar 8.

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. Epub 2011 Jan 23.

Responsible Party:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00073021 History of Changes
Other Study ID Numbers:	2000082
Study First Received:	November 13, 2003
Results First Received:	March 25, 2011
Last Updated:	September 14, 2011
Health Authority:	United States: Food and Drug Administration