Asacol Acute Diverticulitis(DIVA)Study

This study has been completed.

Study NCT00554099 Information provided by Warner Chilcott

First Received on November 2, 2007. Last Updated on June 29, 2011 History of Changes

Results First Received: March 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Diverticulitis
Interventions:	Drug: Mesalamine Drug: Probiotic Drug: Placebo Other: Dietary Advice Drug: Antibiotic for Diverticulitis

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
First patient screened 6 Dec 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization 1:1:1 ratio with subsequent stratification based on number of prior episodes (1 attack vs. more than 1 attack).

Reporting Groups

	Description
Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
Mesalamine	400 mg mesalamine (6 tablets daily)
Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Participant Flow for 2 periods

Period 1: Treatment Period (12 Weeks)

	Placebo	Mesalamine	Mesalamine & Probiotic
STARTED	41	40	36
COMPLETED	29	32	27
NOT COMPLETED	12	8	9
Adverse Event	3	5	1
Physician Decision	3	0	0
Lost to Follow-up	1	0	2
Recurrent diverticulitis,surgery require	1	2	0
Protocol Violation	0	0	2
Withdrawal by Subject	4	1	4

Period 2: Non-Treatment Phase (9 Months)

	Placebo	Mesalamine	Mesalamine & Probiotic
STARTED	29	32	27
COMPLETED	22	27	24
NOT COMPLETED	7	5	3
Lost to Follow-up	1	2	0
Relapse	2	1	1
Withdrawal by Subject	4	2	2

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
Mesalamine	400 mg mesalamine (6 tablets daily)
Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Baseline Measures

	Placebo	Mesalamine	Mesalamine & Probiotic	Total
Number of Participants [units: participants]	41	40	36	117
Age, Customized [units: Participants]
< 65 years	31	28	25	84
>= 65 years	10	12	11	33
Gender [units: participants]
Female	19	23	19	61
Male	22	17	17	56
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	4	2	4	10
Not Hispanic or Latino	37	38	32	107
Unknown or Not Reported	0	0	0	0
Race/Ethnicity, Customized [units: Participants]
Caucasian	39	39	33	111
Black	2	0	2	4
Asian (Oriental)	0	0	1	1
Multi-racial	0	1	0	1
Region of Enrollment [units: participants]
United States	41	40	36	117

Outcome Measures

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1. Primary:

Global Symptom Score (GSS) at Week 12, Primary Efficacy Population [ Time Frame: 12 Weeks ]

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2. Secondary:

Percentage of Responders at Week 12 - ITT Population [ Time Frame: 12 Weeks ]

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3. Secondary:

Percentage of Responders at Week 52 - ITT Population [ Time Frame: 52 Weeks ]

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4. Secondary:

Change in GSS From Baseline to Week 12 - ITT Population [ Time Frame: Baseline to Week 12 ]

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5. Secondary:

Change in GSS From Baseline to Week 52 - ITT Population [ Time Frame: Baseline to Week 52 ]

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6. Secondary:

Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12 [ Time Frame: 12 Weeks ]

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7. Secondary:

Recurrent Diverticulitis, Percentage, ITT Population, Week 12 [ Time Frame: 12 Weeks ]

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8. Secondary:

Recurrent Diverticulitis, Percentage, ITT Population, Week 52 [ Time Frame: 52 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

Responsible Party:	Simon Magowan, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00554099 History of Changes
Other Study ID Numbers:	2007020
Study First Received:	November 2, 2007
Results First Received:	March 14, 2011
Last Updated:	June 29, 2011
Health Authority:	United States: Food and Drug Administration