CompletedNCT00554099Updated Apr 22, 2013Results posted

Asacol Acute Diverticulitis(DIVA)Study

A Phase 2 interventional study of Mesalamine and Probiotic in Diverticulitis, sponsored by Warner Chilcott. Completed at 36 sites in United States. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-04-22.

Sponsored by Warner Chilcott · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 117
Allocation: Randomized
Ages: 35 Years to 85 Years
Sex: All

Study summary

The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.

Read the detailed description

This study is designed to evaluate the safety and efficacy of Asacol® 2.4 g/day in generally healthy, adult patients who have had an attack of acute diverticulitis. The study will evaluate the safety and efficacy of a 12 week treatment with Asacol® followed a 9 month non-treatment observation period in approximately 180 patients with acute diverticulitis.

Conditions studied

Diverticulitis

Browse trials for

Diverticulitis 146

In context

Diverticulitis

146 studies on the registry are indexed under Diverticulitis; 26 are open to participants now.

This study's enrollment of 117 is close to the median of 120 across 71 interventional studies indexed under Diverticulitis.

Browse Diverticulitis studies →

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: 35 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

A clinical diagnosis of acute diverticulitis
Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]; 2-barrier methods [e.g., condom, diaphragm, or spermicide]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)
Willing and able to participate in the study and provide a signed informed consent

Exclusion criteria

Exclusion Criteria:

Presence of diverticular complications (e.g., fistula, abscess, obstruction, stenosis);
Active or recent history (within 6 months) of a peptic ulcer;
Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;
History of major abdominal surgery (as determined by the Investigator);
History of GI surgery within 3 months of diagnosis of acute diverticulitis;
History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);
If female patient, active or recent history of endometriosis or dysmenorrhea;
Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 117 participants (actual)

Study arms

Placebo comparator
Placebo
Days 1 thru Days 10 to 14 (Visit 2): daily antibiotic therapy, dietary advice, and 6 placebo tablets (matching mesalamine) once a day. Visit 2 thru Week 12 : 1 placebo capsule (matching probiotic) and 6 placebo tablets (matching mesalamine) daily.
Drug: Placebo · Other: Dietary Advice · Drug: Antibiotic for Diverticulitis
Active comparator
Mesalamine
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once a day. Visit 2 thru Week 12: 1 placebo capsule (matching probiotic) and 6 - 400 mg mesalamine tablets daily.
Drug: Mesalamine · Other: Dietary Advice · Drug: Antibiotic for Diverticulitis
Active comparator
Mesalamine & Probiotic
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once daily. Visit 2 thru Week 12: 1- Bifidobacterium infantis 35624 capsule and 6 - 400 mg mesalamine tablets daily
Drug: Probiotic · Other: Dietary Advice · Drug: Antibiotic for Diverticulitis

Interventions

DrugMesalamine
6 - 400 mg tablets once daily
DrugProbiotic
Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
Also known as: Align
DrugPlacebo
6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
OtherDietary Advice
Dietary advice
DrugAntibiotic for Diverticulitis
Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.

What researchers measure

Primary outcomes

Global Symptom Score (GSS) at Week 12, Primary Efficacy Population
GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
Time frame: 12 Weeks

Secondary outcomes

Percentage of Responders at Week 12 - ITT Population
Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
Time frame: 12 Weeks
Percentage of Responders at Week 52 - ITT Population
Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
Time frame: 52 Weeks
Change in GSS From Baseline to Week 12 - ITT Population
GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
Time frame: Baseline to Week 12
Change in GSS From Baseline to Week 52 - ITT Population
GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
Time frame: Baseline to Week 52
Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12
Time frame: 12 Weeks
Recurrent Diverticulitis, Percentage, ITT Population, Week 12
At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).
Time frame: 12 Weeks
Recurrent Diverticulitis, Percentage, ITT Population, Week 52
At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).
Time frame: 52 Weeks

Results

Posted Jun 21, 2011

Participant flow

First patient screened 6 Dec 2007

Treatment Period (12 Weeks)

Participant flow — Treatment Period (12 Weeks)
Milestone	Placebo	Mesalamine	Mesalamine & Probiotic
Started	41	40	36
Completed	29	32	27
Not completed	12	8	9
Withdrew: Adverse event	3	5	1
Withdrew: Physician decision	3	0	0
Withdrew: Lost to follow-up	1	0	2
Withdrew: Recurrent diverticulitis,surgery require	1	2	0
Withdrew: Protocol violation	0	0	2
Withdrew: Withdrawal by subject	4	1	4

Non-Treatment Phase (9 Months)

Participant flow — Non-Treatment Phase (9 Months)
Milestone	Placebo	Mesalamine	Mesalamine & Probiotic
Started	29	32	27
Completed	22	27	24
Not completed	7	5	3
Withdrew: Lost to follow-up	1	2	0
Withdrew: Relapse	2	1	1
Withdrew: Withdrawal by subject	4	2	2

Outcome measures

PrimaryGlobal Symptom Score (GSS) at Week 12, Primary Efficacy Population

GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).

Time frame:: 12 Weeks
Reported as:: Mean · Scores on a Scale

Global Symptom Score (GSS) at Week 12, Primary Efficacy Population
Scores on a Scale	Placebo	Mesalamine	Mesalamine & Probiotic
Global Symptom Score (GSS) at Week 12, Primary Efficacy Population	7.3 ± 1.30	4.4 ± 1.07	5.9 ± 1.16

Statistical analysis

Placebo vs Mesalamine · ANCOVA · p = 0.3781 · Mean difference vs. placebo: -3.0Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.
Placebo vs Mesalamine & Probiotic · ANCOVA · p = 0.6285 · Mean difference vs. placebo: -1.4Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.
Mesalamine vs Mesalamine & Probiotic · ANCOVA · p = 0.4365 · Mean difference vs. asacol: 1.6Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.

SecondaryPercentage of Responders at Week 12 - ITT Population

Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).

Time frame:: 12 Weeks
Reported as:: Number · Percentage of Participants

Percentage of Responders at Week 12 - ITT Population
Percentage of Participants	Placebo	Mesalamine	Mesalamine & Probiotic
Percentage of Responders at Week 12 - ITT Population	41.4	62.5	48.1

Statistical analysis

Placebo vs Mesalamine · Cochran-Mantel-Haenszel · p = 0.0576 · Difference vs. placebo: 21.1Stratified by number of diverticulitis attacks.
Placebo vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.3248 · Difference vs. placebo: 6.8Stratified by number of diverticulitis attacks.
Mesalamine vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.8596 · Difference vs. mesalamine: -14.4Stratified by number of diverticulitis attacks.

SecondaryPercentage of Responders at Week 52 - ITT Population

Time frame:: 52 Weeks
Reported as:: Number · Percentage of Participants

Percentage of Responders at Week 52 - ITT Population
Percentage of Participants	Placebo	Mesalamine	Mesalamine & Probiotic
Percentage of Responders at Week 52 - ITT Population	50.0	66.7	29.2

Statistical analysis

Placebo vs Mesalamine · Cochran-Mantel-Haenszel · p = 0.1266 · Difference vs. placebo: 16.7Stratified by number of diverticulitis attacks.
Placebo vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.9288 · Difference vs. placebo: -20.8Stratified by number of diverticulitis attacks.
Mesalamine vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.9962 · Difference vs. placebo: -37.5Stratified by number of diverticulitis attacks.

SecondaryChange in GSS From Baseline to Week 12 - ITT Population

Time frame:: Baseline to Week 12
Reported as:: Mean · Scores on a Scale

Change in GSS From Baseline to Week 12 - ITT Population
Scores on a Scale	Placebo	Mesalamine	Mesalamine & Probiotic
Change in GSS From Baseline to Week 12 - ITT Population	-16.14 ± 2.082	-17.63 ± 1.825	-16.11 ± 2.110

Statistical analysis

Placebo vs Mesalamine · ANOVA · p = 0.3082 · Ls mean difference vs. placebo: -1.400Fixed effects for treatment and number of diverticulitis attacks.
Placebo vs Mesalamine & Probiotic · ANOVA · p = 0.5113 · Ls mean difference vs. placebo: 0.083Fixed effects for treatment and number of diverticulitis attacks.
Mesalamine vs Mesalamine & Probiotic · ANOVA · p = 0.6988 · Ls mean difference vs. mesalamine: 1.483Fixed effects for treatment and number of diverticulitis attacks.

SecondaryChange in GSS From Baseline to Week 52 - ITT Population

Time frame:: Baseline to Week 52
Reported as:: Mean · Scores on a Scale

Change in GSS From Baseline to Week 52 - ITT Population
Scores on a Scale	Placebo	Mesalamine	Mesalamine & Probiotic
Change in GSS From Baseline to Week 52 - ITT Population	-16.82 ± 2.527	-17.30 ± 2.040	-16.00 ± 1.931

Statistical analysis

Placebo vs Mesalamine · ANOVA · p = 0.4448 · Ls mean difference vs. placebo: -0.428Fixed effects for treatment and number of diverticulitis attacks.
Placebo vs Mesalamine & Probiotic · ANOVA · p = 0.6029 · Ls mean difference vs. placebo: 0.825Fixed effects for treatment and number of diverticulitis attacks.
Mesalamine vs Mesalamine & Probiotic · ANOVA · p = 0.6615 · Ls mean difference vs. mesalamine: 1.253Fixed effects for treatment and number of diverticulitis attacks.

SecondaryWithdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12

Time frame:: 12 Weeks
Reported as:: Number · Percentage of Participants

Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12
Percentage of Participants	Placebo	Mesalamine	Mesalamine & Probiotic
Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12	2.4	5.0	0.0

Statistical analysis

Placebo vs Mesalamine · Cochran-Mantel-Haenszel · p = 0.7165 · Difference vs. placebo: 2.6Stratified by number of diverticulitis attacks.
Placebo vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.1708 · Difference vs. placebo: -2.4Stratified by number of diverticulitis attacks.
Mesalamine vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.1039 · Difference vs. mesalamine: -5.0Stratified by number of diverticulitis attacks.

SecondaryRecurrent Diverticulitis, Percentage, ITT Population, Week 12

At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).

Time frame:: 12 Weeks
Reported as:: Number · Percentage of Participants

Recurrent Diverticulitis, Percentage, ITT Population, Week 12
Percentage of Participants	Placebo	Mesalamine	Mesalamine & Probiotic
Recurrent Diverticulitis, Percentage, ITT Population, Week 12	20.0	12.5	11.8

Statistical analysis

Placebo vs Mesalamine · Cochran-Mantel-Haenszel · p = 0.1907 · Difference vs. placebo: -7.5Stratified by number of diverticulitis attacks.
Placebo vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.1730 · Difference vs. placebo: -8.2Stratified by number of diverticulitis attacks.
Mesalamine vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.4613 · Difference vs. mesalamine: -0.7Stratified by number of diverticulitis attacks.

SecondaryRecurrent Diverticulitis, Percentage, ITT Population, Week 52

At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).

Time frame:: 52 Weeks
Reported as:: Number · Percentage of Participants

Recurrent Diverticulitis, Percentage, ITT Population, Week 52
Percentage of Participants	Placebo	Mesalamine	Mesalamine & Probiotic
Recurrent Diverticulitis, Percentage, ITT Population, Week 52	31.0	28.1	37.0

Statistical analysis

Placebo vs Mesalamine · Cochran-Mantel-Haenszel · p = 0.3983 · Difference vs. placebo: -2.9Stratified by number of diverticulitis attacks.
Placebo vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.6721 · Difference vs. placebo: 6.0Stratified by number of diverticulitis attacks.
Mesalamine vs Mesalamine & Probiotic · Cochran-Mantel-Haenszel · p = 0.7703 · Difference vs. mesalamine: 8.9Stratified by number of diverticulitis attacks.

Adverse events

Collected over 6 Dec 2007 thru 1 Mar 2010. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	6/41 (14.6%)	32/41 (78%)
Mesalamine	—	5/40 (12.5%)	37/40 (92.5%)
Mesalamine & Probiotic	—	0/36 (0%)	26/36 (72.2%)

Most frequent serious events

Showing 10 of 19

Most frequent serious events
Event	Placebo	Mesalamine	Mesalamine & Probiotic
DiverticulitisInfections and infestations	2/41	0/40	0/36
Atrioventricular BlockCardiac disorders	1/29	0/32	0/27
Benign Ovarian TumourNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/29	0/32	0/27
Colon OperationSurgical and medical procedures	1/29	0/32	0/27
GastritisGastrointestinal disorders	1/29	0/32	0/27
SyncopeNervous system disorders	1/29	0/32	0/27
Arterial Thrombosis LimbVascular disorders	0/29	1/32	0/27
BronchopneumoniaInfections and infestations	0/29	1/32	0/27
Tendon RuptureInjury, poisoning and procedural complications	0/29	1/32	0/27
Vascular PseudoaneurysmInjury, poisoning and procedural complications	0/29	1/32	0/27

Most frequent other events

Showing 10 of 89

Most frequent other events
Event	Placebo	Mesalamine	Mesalamine & Probiotic
Abdominal PainGastrointestinal disorders	1/41	12/40	4/36
ConstipationGastrointestinal disorders	5/41	3/40	3/36
PyrexiaGeneral disorders	3/29	1/32	2/27
DiarrhoeaGastrointestinal disorders	2/41	4/40	3/36
NauseaGastrointestinal disorders	4/41	1/40	1/36
PainGeneral disorders	0/41	0/40	3/36
HaematocheziaGastrointestinal disorders	0/41	3/40	0/36
Upper Respiratory Tract InfectionInfections and infestations	1/29	1/32	2/27
Abdominal Pain LowerGastrointestinal disorders	3/41	0/40	2/36
Back PainMusculoskeletal and connective tissue disorders	2/41	1/40	2/36

Baseline characteristics

Age, Customized
Age, Customized(Participants)	Placebo	Mesalamine	Mesalamine & Probiotic	Total
< 65 years	31	28	25	84
>= 65 years	10	12	11	33

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Mesalamine	Mesalamine & Probiotic	Total
Female	19	23	19	61
Male	22	17	17	56

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	Mesalamine	Mesalamine & Probiotic	Total
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
Race/Ethnicity, Customized(Participants)	Placebo	Mesalamine	Mesalamine & Probiotic	Total
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
Region of Enrollment(participants)	Placebo	Mesalamine	Mesalamine & Probiotic	Total
United States	41	40	36	117

Study locations

36 sites

Research Site
Tucson, Arizona, United States
Research Facility
Los Angeles, California, United States
Research Site
Merced, California, United States
Research Site
Oakland, California, United States
Research Facility
Orange, California, United States
Research Site
Palm Springs, California, United States
Research Site
Pasadena, California, United States
Research Site
Lafayette, Colorado, United States
Research Site
Littleton, Colorado, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Jacksonsville, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Winter Park, Florida, United States
Research Facility
Zephyrhills, Florida, United States
Research Site
Pratt, Kansas, United States
Research Site
Monroe, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Chesterfield, Michigan, United States
Research Site
Tupelo, Mississippi, United States
Research Site
Mexico, Missouri, United States
Research Facility
Cedar Knolls, New Jersey, United States
Research Site
Great Neck, New York, United States
Research Site
Lake Success, New York, United States
Research Site
Setauket, New York, United States
Research Site
Asheville, North Carolina, United States
Research Site
Greenville, North Carolina, United States
Research Facility
Harrisburg, North Carolina, United States
Research Site
Morganton, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cranston, Rhode Island, United States
Research Site
Longview, Texas, United States
Research Site
Odessa, Texas, United States
Research Site
Chesapeake, Virginia, United States
Research Facility
Monroe, Wisconsin, United States

References and documents

Publications

Stollman N, Magowan S, Shanahan F, Quigley EM; DIVA Investigator Group. A randomized controlled study of mesalamine after acute diverticulitis: results of the DIVA trial. J Clin Gastroenterol. 2013 Aug;47(7):621-9. doi: 10.1097/MCG.0b013e31828003f6. PubMed 23426454 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00554099
Lead sponsor: Warner Chilcott
Responsible party: Sponsor
First posted: Nov 6, 2007
Start date: Nov 2007
Primary completion: Mar 2010
Completion: Mar 2010
Results posted: Jun 21, 2011
Last update: Apr 22, 2013

Study contacts

Ana Balske, MD, PhD

study director · Procter and Gamble

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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Asacol Acute Diverticulitis(DIVA)Study

Study summary

Conditions studied

Browse trials for

In context

Diverticulitis

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria