Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00554099 · ClinicalTrials.gov registry record · Phase 2
Asacol Acute Diverticulitis(DIVA)Study
A Phase 2 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
NCT00554099: Completed Phase 2 study, sponsored by Warner Chilcott.
NCT00554099 is a Phase 2 study that has completed, run by Warner Chilcott. The registered enrollment target is 117 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00554099, a Phase 2 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
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.
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG Mesalamine
- DRUG Probiotic
- OTHER Dietary Advice
- DRUG Antibiotic for Diverticulitis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2007-11 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00554099 record still lists
NCT00554099 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00554099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00554099 about?
NCT00554099 is a clinical study titled "Asacol Acute Diverticulitis(DIVA)Study". 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.
What is the current status of trial NCT00554099?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2007-11. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00554099?
The interventions under investigation include: Placebo (DRUG), Mesalamine (DRUG), Probiotic (DRUG), Dietary Advice (OTHER), Antibiotic for Diverticulitis (DRUG).
Who is sponsoring clinical trial NCT00554099?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00554099's enrollment target sits among peer trials
117 623rd of 2000 higher than 1,378 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03539822 · 117 participants · Phase 1
Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
- NCT03786692 · 117 participants · Phase 2
Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC
- NCT04479696 · 117 participants · NA
Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors
- NCT04940585 · 117 participants · NA
ROSE in Sunset Park
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia