Crohn's DiseasePhase 2NCT00130390
Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease
A Phase 2 study testing Nitazoxanide in people with Crohn's Disease, run by Romark Laboratories L.C. at 13 sites in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's disease in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2005to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosis of Crohn's disease with colonic or perianal involvement confirmed by endoscopic, histologic and/or radiologic data.
- CDAI score ≥200 and ≤400.
Who cannot join
- Subjects known to have stool positive for Clostridium difficile toxin A or B, bacterial enteric pathogens, rotavirus, Cryptosporidium species (spp.), and/or ova/parasites.
- Evidence of bowel obstruction.
- Females that are pregnant, breast-feeding or not using birth control and are sexually active.
- Serious systemic disorders incompatible with the study.
- History of hypersensitivity to nitazoxanide or any inactive ingredient in the formulation.
- Uncontrolled gastro-intestinal bleeding.
Show all 13Show fewer
- Evidence of intestinal abscess, non-perianal fistula or stricture.
- Patients who have received antibiotics in the past 7 days.
- Patients receiving >20 mg of prednisone, or its equivalent.
- Patients receiving Anucort-HC or rectal steroids.
- Patients receiving immunosuppressive therapy that has not been stabilized.
- Patients who have received TNF-alpha inhibitor treatments such as infliximab or other biological agents within three months prior to start of treatment.
- Patients with Crohn's disease confined to the esophagus, stomach and small bowel.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Gasteroenterology Associates
Baton Rouge, Louisiana, 70809
Greater Cincinnati Gastroenterology Associates
Cincinnati, Ohio, 45219
Memphis Gastroenterology Group
Germantown, Tennessee, 38138
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021
Gastrointestinal Associates, LLC
Kingsport, Tennessee, 37660
Atlanta Gastroenterology
Marietta, Georgia, 30067
Digestive Research & Infusion Institute
Mayfield Heights, Ohio, 44124
Nashville Medical Research
Nashville, Tennessee, 37205
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
Minnesota Gastroenterology, P.A., Clinical Research Division
Plymouth, Minnesota, 55446
Romark Laboratories, L.C.
Tampa, Florida, 33607
Atlanta Gastroenterology
Woodstock, Georgia, 30189
Florida medical Clinic, P.A.
Zephyrhills, Florida, 33542
About this study
Official title: Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease in Adults
The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's disease in adults.
Read the detailed description
There is a significant need for a safe and effective treatment of Crohn's disease. It is recognized that bacteria in the gut lumen may have a role in the etiology and/or symptoms of this disease. Antimicrobials have often been used in treating Crohn's disease although their effectiveness has not been well established. Pro-inflammatory cytokines are also believed to play an important role in this disease. Nitazoxanide, a thiazolide anti-infective, is active in vitro against a broad spectrum of anaerobic bacteria, and it inhibits secretion of pro-inflammatory cytokines including IL-2, -4, -5, -6, -8, -10 and TNF alpha. The drug is also highly concentrated in the gastrointestinal tract. With these characteristics, nitazoxanide offers a unique approach to treatment of Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- Nitazoxanide, Placebo
- Keywords
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Alinia
One nitazoxanide 500 mg tablet twice daily for 28 days
PlaceboOther
One placebo tablet twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One nitazoxanide 500 mg tablet twice daily for 28 days Receives: Drug: Nitazoxanide |
| 2 | Placebo comparator | One placebo tablet twice daily for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Crohn's Disease Activity Index (CDAI)
Measured: Day 14
Secondary outcomes (1)
Clinical response; remission; change in C-reactive protein; reduction in steroid use; fistula response; change in Perianal Disease Activity Index (PDAI); change in plasma cytokine levels
Measured: Days 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2007
- Study completionJul 2008
Why it stopped: terminated due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Carrion, MD, Study director, Romark Laboratories L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130390
- Sponsor's protocol ID
- RM01-2018
- Status last verified
- May 2012
- First submitted
- 12 Aug 2005
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease in Adults
- ClinicalTrials.gov ID
- NCT00130390
- Acronym / sponsor ID
- RM01-2018
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to slow recruitment
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's disease in adults.
Detailed description
There is a significant need for a safe and effective treatment of Crohn's disease. It is recognized that bacteria in the gut lumen may have a role in the etiology and/or symptoms of this disease. Antimicrobials have often been used in treating Crohn's disease although their effectiveness has not been well established. Pro-inflammatory cytokines are also believed to play an important role in this disease. Nitazoxanide, a thiazolide anti-infective, is active in vitro against a broad spectrum of anaerobic bacteria, and it inhibits secretion of pro-inflammatory cytokines including IL-2, -4, -5, -6, -8, -10 and TNF alpha. The drug is also highly concentrated in the gastrointestinal tract. With these characteristics, nitazoxanide offers a unique approach to treatment of Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NitazoxanideOne nitazoxanide 500 mg tablet twice daily for 28 days |
| 2 | Placebo comparator | Other: PlaceboOne placebo tablet twice daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Diagnosis of Crohn's disease with colonic or perianal involvement confirmed by endoscopic, histologic and/or radiologic data.
- CDAI score ≥200 and ≤400.
Key exclusion criteria (13 listed)
- Subjects known to have stool positive for Clostridium difficile toxin A or B, bacterial enteric pathogens, rotavirus, Cryptosporidium species (spp.), and/or ova/parasites.
- Evidence of bowel obstruction.
- Females that are pregnant, breast-feeding or not using birth control and are sexually active.
- Serious systemic disorders incompatible with the study.
- History of hypersensitivity to nitazoxanide or any inactive ingredient in the formulation.
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 |
|---|---|---|
| NitazoxanideAlso: AliniaOne nitazoxanide 500 mg tablet twice daily for 28 days | Drug | 1 |
| PlaceboOne placebo tablet twice daily for 28 days | Other | 2 |
Primary outcome
Change in Crohn's Disease Activity Index (CDAI)
Time frame: Day 14
1 secondary outcome
Clinical response; remission; change in C-reactive protein; reduction in steroid use; fistula response; change in Perianal Disease Activity Index (PDAI); change in plasma cytokine levels
Time frame: Days 14 and 28
Results and safety
The study was stopped early (reason given: terminated due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Maria Carrion, MD study director
Romark Laboratories L.C.
13 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 Nitazoxanide in people with Crohn's Disease, run by Romark Laboratories L.C. at 13 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 13 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: stopped early, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study was stopped early (reason given: terminated due to slow recruitment). Results are not available in the source record.
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?
Change in Crohn's Disease Activity Index (CDAI) (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2012.