Ulcerative ColitisPhase 3NCT00767728
Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis
A Phase 3 study testing Granulated mesalamine in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Granulated mesalamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Oct 2007
- 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
- Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month
- Greater than 18 years of age
Who cannot join
- Allergy/intolerance to aspirin, mesalamine, or other salicylates
- Prior bowel surgery other than appendectomy
- Pregnancy, at risk of pregnancy, or lactating
- HIV or hepatitis B or C
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis
The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.
Read the detailed description
This is a Phase 3 study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared to placebo in subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 or 2 treatments: 1.5g eMG (4 capsules total) or matching placebo capsules QD for 6 months.
The study consists of a screening phase (completed within 7 days prior to randomization), a treatment phase (6 months), and a follow-up visit (2 weeks after end-of-study [EOS] visit.) The treatment phase consists of 4 scheduled study visits: visit 1 (baseline/randomization (day 1), visit 2 (month 1), visit 3 (month 3), visit 4 (EOS (month 6).
Primary objective:
To compare the maintenance of remission from mild to moderate ulcerative colitis as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) of 1.5 g QD, as compared with placebo.
Secondary objective:
To compare the safety and tolerability of long-term dosing with eMG at 1.5 g QD as compared to placebo in the maintenance of remission from mild to moderate UC.
- Conditions
- Ulcerative Colitis
- Being tested
- Granulated mesalamine, Placebo
- Keywords
- UC, ulcerative colitis, IBD, Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulated mesalamineDrug
0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning.
PlaceboDrug
Matching placebo capsules (4 capsules) were administered orally QD, in the morning.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Mesalamine pellets Receives: Drug: Granulated mesalamine |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subject who were relapse free after 6 months of treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startDec 2004
- Primary completionAug 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767728
- Sponsor's protocol ID
- MPUC3004
- Status last verified
- Nov 2019
- First submitted
- 17 Sep 2008
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Zakko SF, Gordon GL, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP, Lichtenstein GR. Once-daily mesalamine granules for maintaining remission of ulcerative colitis: pooled analysis of efficacy, safety, and prognostic factors. Postgrad Med. 2016;128(3):273-81. doi: 10.1080/00325481.2016.1152876. Epub 2016 Mar 1.
PubMed 26861051Lichtenstein GR, Gordon GL, Zakko S, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP. Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission. Dig Dis Sci. 2016 Jan;61(1):221-9. doi: 10.1007/s10620-015-3866-7. Epub 2015 Nov 12.
PubMed 26563167Lichtenstein GR, Zakko S, Gordon GL, Murthy U, Sedghi S, Pruitt R, Merchant K, Bortey E, Forbes WP. Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: a pooled analysis from two randomised controlled trials. Aliment Pharmacol Ther. 2012 Jul;36(2):126-34. doi: 10.1111/j.1365-2036.2012.05142.x. Epub 2012 May 23.
PubMed 22617015
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00767728
- Acronym / sponsor ID
- MPUC3004
- Conditions
- Ulcerative Colitis
- Keywords
- UC, ulcerative colitis, IBD, Inflammatory Bowel Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 7 Oct 2008 (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 purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.
Detailed description
This is a Phase 3 study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared to placebo in subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 or 2 treatments: 1.5g eMG (4 capsules total) or matching placebo capsules QD for 6 months.
The study consists of a screening phase (completed within 7 days prior to randomization), a treatment phase (6 months), and a follow-up visit (2 weeks after end-of-study [EOS] visit.) The treatment phase consists of 4 scheduled study visits: visit 1 (baseline/randomization (day 1), visit 2 (month 1), visit 3 (month 3), visit 4 (EOS (month 6).
Primary objective:
To compare the maintenance of remission from mild to moderate ulcerative colitis as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) of 1.5 g QD, as compared with placebo.
Secondary objective:
To compare the safety and tolerability of long-term dosing with eMG at 1.5 g QD as compared to placebo in the maintenance of remission from mild to moderate UC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Granulated mesalamineMesalamine pellets |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month
- Greater than 18 years of age
Key exclusion criteria (4 listed)
- Allergy/intolerance to aspirin, mesalamine, or other salicylates
- Prior bowel surgery other than appendectomy
- Pregnancy, at risk of pregnancy, or lactating
- HIV or hepatitis B or C
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 |
|---|---|---|
| Granulated mesalamine0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning. | Drug | 1 |
| PlaceboMatching placebo capsules (4 capsules) were administered orally QD, in the morning. | Drug | 2 |
Primary outcome
Proportion of subject who were relapse free after 6 months of treatment
Time frame: 6 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 27 Nov 2019.
- Derived from this study: PubMed 26861051Zakko SF, Gordon GL, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP, Lichtenstein GR. Once-daily mesalamine granules for maintaining remission of ulcerative colitis: pooled analysis of efficacy, safety, and prognostic factors. Postgrad Med. 2016;128(3):273-81. doi: 10.1080/00325481.2016.1152876. Epub 2016 Mar 1.
- Derived from this study: PubMed 26563167Lichtenstein GR, Gordon GL, Zakko S, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP. Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission. Dig Dis Sci. 2016 Jan;61(1):221-9. doi: 10.1007/s10620-015-3866-7. Epub 2015 Nov 12.
- Derived from this study: PubMed 22617015Lichtenstein GR, Zakko S, Gordon GL, Murthy U, Sedghi S, Pruitt R, Merchant K, Bortey E, Forbes WP. Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: a pooled analysis from two randomised controlled trials. Aliment Pharmacol Ther. 2012 Jul;36(2):126-34. doi: 10.1111/j.1365-2036.2012.05142.x. Epub 2012 May 23.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Granulated mesalamine in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 1 site 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 2 inclusion and 4 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 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Proportion of subject who were relapse free after 6 months of treatment (time frame: 6 months). 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 NCT00767728, which also lists 3 linked publications.
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 27 Nov 2019.