DiverticulitisPhase 2NCT00554099

Asacol Acute Diverticulitis(DIVA)Study

A Phase 2 study testing Mesalamine, Probiotic and Dietary Advice in people with Diverticulitis, run by Warner Chilcott at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 35 to 85 years
Conditions the study is for: Diverticulitis
What is being tested?: Mesalamine, Probiotic and Dietary Advice
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 117 participants
Where: 36 sitesUnited States
Study dates: Nov 2007to Mar 2010
Phase: Phase 2
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 35 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

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

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of a 12 Week Treatment of Acute Diverticulitis With Asacol® 2.4 g/Day (400 mg Mesalamine Tablet), Followed by a 9 Month Treatment-free Observation Period

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: Diverticulitis
Being tested: Mesalamine, Probiotic, Placebo, Dietary Advice, Antibiotic for Diverticulitis
Medical subject headings: Diverticulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MesalamineDrug
6 - 400 mg tablets once daily
ProbioticDrug
Also called Align
Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
PlaceboDrug
6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
Dietary AdviceOther
Dietary advice
Antibiotic for DiverticulitisDrug
Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.

Study groups in NCT00554099
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: Placebo; Other: Dietary Advice; Drug: Antibiotic for Diverticulitis
Mesalamine	Active comparator	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. Receives: Drug: Mesalamine; Other: Dietary Advice; Drug: Antibiotic for Diverticulitis
Mesalamine & Probiotic	Active comparator	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 Receives: Drug: Probiotic; Other: Dietary Advice; Drug: Antibiotic for Diverticulitis

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 Weeks

Secondary outcomes (7)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline to Week 52
Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12
Measured: 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).
Measured: 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).
Measured: 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Mar 2010

First posted6 Nov 2007 (estimated)
Study startNov 2007
Primary completionMar 2010
Study completionMar 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiverticulitisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00554099
Sponsor's protocol ID: 2007020
Status last verified: Apr 2013
First submitted: 2 Nov 2007
Last updated: 22 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
Diverticulitis
RecruitingPhase 2
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
Acute Uncomplicated Diverticulitis
Not yet recruitingObservational study
Analysis of the Role of the Microbiota in Diverticular Disease
Diverticular Disease of Colon, Acute Diverticulitis
Not yet recruitingObservational study
Differentiating Right-sided Epiploic Appendagitis From Diverticulitis
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Enrolling by invitationObservational study
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All Diverticulitis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of a 12 Week Treatment of Acute Diverticulitis With Asacol® 2.4 g/Day (400 mg Mesalamine Tablet), Followed by a 9 Month Treatment-free Observation Period
ClinicalTrials.gov ID: NCT00554099
Acronym / sponsor ID: 2007020
Conditions: Diverticulitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 6 Nov 2007 (estimated)
Results: Posted 21 Jun 2011

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 Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo, Other: Dietary Advice, Drug: Antibiotic for DiverticulitisDays 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.
Mesalamine	Active comparator	Drug: Mesalamine, Other: Dietary Advice, Drug: Antibiotic for DiverticulitisDays 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.
Mesalamine & Probiotic	Active comparator	Drug: Probiotic, Other: Dietary Advice, Drug: Antibiotic for DiverticulitisDays 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

Who may qualify

Ages: 35 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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;

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
Mesalamine6 - 400 mg tablets once daily	Drug	Mesalamine
ProbioticAlso: AlignOnce capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)	Drug	Mesalamine & Probiotic
Placebo6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.	Drug	Placebo
Dietary AdviceDietary advice	Other	Mesalamine, Mesalamine & Probiotic, Placebo
Antibiotic for DiverticulitisPhysician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.	Drug	Mesalamine, Mesalamine & Probiotic, Placebo

Primary outcome

Global Symptom Score (GSS) at Week 12, Primary Efficacy Population
Time frame: 12 Weeks
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).

7 secondary outcomes

Percentage of Responders at Week 12 - ITT Population
Time frame: 12 Weeks
Percentage of Responders at Week 52 - ITT Population
Time frame: 52 Weeks
Change in GSS From Baseline to Week 12 - ITT Population
Time frame: Baseline to Week 12
Change in GSS From Baseline to Week 52 - ITT Population
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
Time frame: 12 Weeks
Recurrent Diverticulitis, Percentage, ITT Population, Week 52
Time frame: 52 Weeks

Results and safety

Results posted to the registry on 21 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	41	29
Mesalamine	40	32
Mesalamine & Probiotic	36	27

Primary outcome: Global Symptom Score (GSS) at Week 12, Primary Efficacy Population

Time frame: 12 Weeks. Mean (Standard Error). Unit: Scores on a Scale

Measure	Placebo n = 41	Mesalamine n = 40	Mesalamine & Probiotic n = 36
Value	7.3 (1.30)	4.4 (1.07)	5.9 (1.16)

Placebo vs Mesalamine: Mean Difference vs. Placebo: -3.0, p = 0.3781, ANCOVA
Placebo vs Mesalamine & Probiotic: Mean Difference vs. Placebo: -1.4, p = 0.6285, ANCOVA
Mesalamine vs Mesalamine & Probiotic: Mean Difference vs. Asacol: 1.6, p = 0.4365, ANCOVA

Population analysed: Primary Efficacy Population - Subset of ITT population including only patients with GSS value at Week 12 and baseline GSS of at least 12.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 Dec 2007 thru 1 Mar 2010. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of 41 (14.6%)	32 of 41 (78%)	Not reported
Mesalamine	5 of 40 (12.5%)	37 of 40 (92.5%)	Not reported
Mesalamine & Probiotic	0 of 36 (0%)	26 of 36 (72.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23426454Stollman 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.

Related trials for Diverticulitis

Not yet recruiting
Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
Diverticulitis
RecruitingPhase 2
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
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Analysis of the Role of the Microbiota in Diverticular Disease
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Differentiating Right-sided Epiploic Appendagitis From Diverticulitis
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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.

Ana Balske, MD, PhD study director

Procter and Gamble

36 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesalamine, Probiotic and Dietary Advice in people with Diverticulitis, run by Warner Chilcott at 36 sites in United States.

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Jun 2011). 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?

Global Symptom Score (GSS) at Week 12, Primary Efficacy Population (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00554099, which also lists 1 linked publication.

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 22 Apr 2013.