Mild to Moderate Ulcerative ColitisPhase 3NCT01045018
A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
A Phase 3 study testing Mesalamine in people with Mild to Moderate Ulcerative Colitis, run by EMET Pharmaceuticals, LLC.
Trial summary
The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were: To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and To evaluate the safety of MDRT 2.4 g per day (800 mg three… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Ulcerative Colitis
- What is being tested?
- Mesalamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2008to Aug 2009
- Phase
- Phase 3
- 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
- Adults with newly diagnosed ulcerative colitis or with relapse following prior treatment and who met all the following criteria were eligible for participation in the study:
- IRB approved consent form signed and dated prior to any study-related activities
- Male or, if female, had undergone sterilization (hysterectomy or bilateral tubal ligation), was post-menopausal (defined as 1 year without menses) or has a negative pregnancy test at screening and, if heterosexually active, had used and agreed to continue to use: double-barrier method of contraception (condom and spermicide), oral or patch contraceptives, intrauterine device, or was in a monogamous relationship with a partner who had undergone a vasectomy.
- 18 years of age or older
- Newly diagnosed with ulcerative colitis or relapsed following prior treatment
- Patient had not taken > 1.6 g/day of mesalamine or equivalent for 14 days prior to randomization
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- Disease extending ≥ 15 cm above the anal verge on screening sigmoidoscopy or colonoscopy with confirming biopsy
- Mild to moderate ulcerative colitis, defined as a Disease Activity Index (DAI) score between 4 and 9, inclusive, at study entry, and with a PGA of 1 or 2 and mucosal appearance (determined by endoscopy exam) score of 1 or 2 (mild/moderate)
- Able and willing to have kept a daily diary during the study
Who cannot join
- Treatment with topical rectal, oral, or intravenous (IV) corticosteroids within 30 days of screening or immunosuppressives (e.g. azathioprine, 6-mercaptopurine) within the 90 days immediately preceding Screening
- Use of rectal - administered aminosalicylates within 7 days of randomization
- Patient had taken greater than 1.6 g/day of mesalamine or equivalent within 14 days of randomization
- Crohn's disease, ischemic colitis, or disease of bacterial origin
- Known allergy or hypersensitivity to aspirin or salicylate compounds
- History of or laboratory results showing significant hepatic or renal disease or other significant medical condition which in the opinion of the investigator precluded participation in the study based on efficacy/safety assessments
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- History of cancer other than basal cell carcinoma within the five years immediately preceding study entry
- In relapse for > 3 weeks prior to the screening visit
- Proctitis below 15 cm from the anal verge
- History of or current gastrointestinal bleeding other than bloody stools associated with ulcerative colitis
- History of bleeding disorder
- Active peptic ulcer disease, history of gastrointestinal obstruction including severe constipation, or anatomic abnormality of the GI tract
- Previous colonic surgery
- History of alcohol or other substance abuse within the year immediately preceding anticipated study entry
- HIV positive
- > 6 bloody stools per day
- Positive stool culture for ova and/or parasites, enteric pathogens including Salmonella, Shigella, Yersinia, and Campylobacter, or positive stool assay for C. difficile toxin
- Pregnant or breast feeding
- Used an investigational drug in the 30 days prior to randomization
- BUN or serum creatinine levels of 1.5 times the upper limit of normal (ULN) or liver enzyme levels > 2 times the ULN
About this study
Official title: BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative Colitis
The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were:
- To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and
- To evaluate the safety of MDRT 2.4 g per day (800 mg three times daily) compared to placebo.
Read the detailed description
This was a multi-center, randomized, parallel-groups comparison of two mesalamine products for treatment of ulcerative colitis. Patients were randomly assigned in an optimized 2:2:1 ratio to MDRT 2.4 g/day, Asacol 2.4 g/day, or placebo. The study was partially blinded due to the difficulties associated with creating placebo that matched both MDRT and Asacol; the placebo matched the MDRT formulation. Placebo groups served as control in the parallel group comparison between MDRT and Asacol. Patients were treated for 6 weeks after randomization and followed through Day 56, which was considered of sufficient length to accommodate any safety issues and to assess efficacy based upon prior clinical trials of mesalamine in patients with mild to moderate active UC as described in the introduction
- Conditions
- Mild to Moderate Ulcerative Colitis
- Being tested
- Placebo, Mesalamine
- Keywords
- colitis, ulcerative, ulcerative colitis
- Medical subject headings
- Colitis, Ulcer, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo 400 mg
MesalamineDrug
MesalamineDrug
| Study group | Role | What they receive |
|---|---|---|
| mesalamine 400 mg tablet | Active comparator | Not described Receives: Drug: Mesalamine |
| Asacol 400 mg Delayed Release Tablet | Active comparator | Not described Receives: Drug: Mesalamine |
| Placebo delayed release tablet | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success: Responders are patients in remission or who do not require use of rescue medication for symptomatic relief of UC at week 6 Treatment benefit: Improvement at endpoint compared to baseline Treatment Failure: Increase or no improvement
Measured: 4 months
Secondary outcomes (1)
Tolerability and safety will be determined by evaluation of AEs, SAEs, hematology, serum chemistry and urinalysis
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Ulcerative ColitisStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- EMET Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eagle Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045018
- Sponsor's protocol ID
- EMET 001
- Status last verified
- Dec 2009
- First submitted
- 17 Dec 2009
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01045018
- Acronym / sponsor ID
- EMET 001
- Conditions
- Mild to Moderate Ulcerative Colitis
- Keywords
- colitis, ulcerative, ulcerative colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- EMET Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Eagle Pharmaceuticals, Inc.
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Jan 2010 (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 objectives of this bioequivalence study in patients with ulcerative colitis (UC) were:
- To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and
- To evaluate the safety of MDRT 2.4 g per day (800 mg three times daily) compared to placebo.
Detailed description
This was a multi-center, randomized, parallel-groups comparison of two mesalamine products for treatment of ulcerative colitis. Patients were randomly assigned in an optimized 2:2:1 ratio to MDRT 2.4 g/day, Asacol 2.4 g/day, or placebo. The study was partially blinded due to the difficulties associated with creating placebo that matched both MDRT and Asacol; the placebo matched the MDRT formulation. Placebo groups served as control in the parallel group comparison between MDRT and Asacol. Patients were treated for 6 weeks after randomization and followed through Day 56, which was considered of sufficient length to accommodate any safety issues and to assess efficacy based upon prior clinical trials of mesalamine in patients with mild to moderate active UC as described in the introduction
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mesalamine 400 mg tablet | Active comparator | Drug: Mesalamine |
| Asacol 400 mg Delayed Release Tablet | Active comparator | Drug: Mesalamine |
| Placebo delayed release tablet | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults with newly diagnosed ulcerative colitis or with relapse following prior treatment and who met all the following criteria were eligible for participation in the study:
- IRB approved consent form signed and dated prior to any study-related activities
- Male or, if female, had undergone sterilization (hysterectomy or bilateral tubal ligation), was post-menopausal (defined as 1 year without menses) or has a negative pregnancy test at screening and, if heterosexually active, had used and agreed to continue to use: double-barrier method of contraception (condom and spermicide), oral or patch contraceptives, intrauterine device, or was in a monogamous relationship with a partner who had undergone a vasectomy.
- 18 years of age or older
- Newly diagnosed with ulcerative colitis or relapsed following prior treatment
Key exclusion criteria (20 listed)
- Treatment with topical rectal, oral, or intravenous (IV) corticosteroids within 30 days of screening or immunosuppressives (e.g. azathioprine, 6-mercaptopurine) within the 90 days immediately preceding Screening
- Use of rectal - administered aminosalicylates within 7 days of randomization
- Patient had taken greater than 1.6 g/day of mesalamine or equivalent within 14 days of randomization
- Crohn's disease, ischemic colitis, or disease of bacterial origin
- Known allergy or hypersensitivity to aspirin or salicylate compounds
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 |
|---|---|---|
| Placeboplacebo 400 mg | Drug | Placebo delayed release tablet |
| Mesalamine | Drug | mesalamine 400 mg tablet |
| Mesalamine | Drug | Asacol 400 mg Delayed Release Tablet |
Primary outcome
Treatment Success: Responders are patients in remission or who do not require use of rescue medication for symptomatic relief of UC at week 6 Treatment benefit: Improvement at endpoint compared to baseline Treatment Failure: Increase or no improvement
Time frame: 4 months
1 secondary outcome
Tolerability and safety will be determined by evaluation of AEs, SAEs, hematology, serum chemistry and urinalysis
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesalamine in people with Mild to Moderate Ulcerative Colitis, run by EMET Pharmaceuticals, LLC.
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 9 inclusion and 20 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 8 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment Success: Responders are patients in remission or who do not require use of rescue medication for symptomatic relief of UC at week 6 Treatment benefit: Improvement at endpoint compared to baseline Treatment Failure: Increase or no improvement (time frame: 4 months). 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 8 Jan 2010.