Ulcerative ColitisPhase 3NCT00326209
Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
A Phase 3 study testing Encapsulated Mesalamine Granules (eMG) in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 61 sites in United States.
Trial summary
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP]) in participants with ulcerative colitis currently in remission. 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?
- Encapsulated Mesalamine Granules (eMG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 61 sitesUnited States
- Study dates
- 22 Dec 2005to 5 May 2008
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities.
- Participant has successfully participated in a previous MP clinical study per investigator's discretion with successful participation minimally defined as compliant with study-related procedures and study drug dosing schedule in the previous study and did not discontinue from the previous study due to study drug-related AE(s) or if new participants:
- Participant is a male or,
- If the participant is female, she is eligible to enter if she is of:
- Non-childbearing potential (that is; physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses); or childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following:
- Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 6-month Treatment Phase, and the 2-week follow-up phase.
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- Oral contraceptives administered for at least 2 monthly cycles prior to study drug administration during all 6 months of study drug administration and administered for 1 monthly cycle following completion of the study.
- An intrauterine device (IUD), inserted by a qualified clinician, with published data showing that the lowest expected failure rate is less than (<)1% per year (not all IUDs meet this criterion).
- Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly cycle prior to the study drug administration, during all 6 months of study drug administration, and administered for 1 monthly cycle following study completion. Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered for at least 2 monthly cycles prior to study drug administration and administered for 2 monthly cycles following study completion.
- Partner has undergone vasectomy and participant is in a monogamous relationship.
- The investigator is responsible for determining whether the participant has adequate birth control for study participation.
- Participant is greater than or equal to (≥) 18 years of age. c. Participant has historically confirmed diagnosis (physician letter for newly/recently diagnosed and by medical records for previously diagnosed participants) of mild to moderate UC in remission for greater than (>) 1 month and <12 months.
- Confirmed current remission defined as both: A screening rectal bleeding score of 0 as described in the Disease Activity Index (DAI) (Sutherland Index) where 0 = None A screening sigmoidoscopy score of 0 to 1 for mucosal appearance as described in the (Sutherland Index where 0 = intact mucosa with preserved or distorted vessels and 1 = Erythema, decreased vascular pattern, granularity, no mucosal hemorrhage.
- Participant and investigator consider there is the potential for benefit to the participant with MP treatment.
- Participant is capable and willing to comply with all study procedures.
Who cannot join
- Participant has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
- If a new participant, the following additional exclusion criteria will apply:
- Participant has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
- Participant has an abnormal clinical lab result which in the opinion of the investigator is significant enough to prevent participant's enrollment in the study.
- Participant or participant's parents are known to have phenylketonuria.
- Participant has participated in an investigational drug or device study within the 30 days prior to study screening.
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- Participant shows evidence of current excessive alcohol consumption or drug dependence.
- Participant has uncontrolled, clinically significant renal disease manifested by 1.5 * ULN of serum creatinine or blood urea nitrogen (BUN) levels.
- Participant has calculated creatinine clearance level of <60 mL/min
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
AGMG Clinical Research
Anaheim, California, 92801
Northwest Gastroenterologists S.C.
Arlington Heights, Illinois, 60005
Consultative Gastroenterology
Atlanta, Georgia, 30308
Digestive Care Associates
Austell, Georgia, 30106
Sinai Medical Office Building
Baltimore, Maryland, 21215
Lovelace Scientific Resources
Beverly Hills, California, 90211
Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010
Clinical Research of Tampa Bay, Inc.
Brooksville, Florida, 34613
Charleston Gastroenterology Specialists, LLC
Charleston, South Carolina, 29414
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
New River Research Institute
Christiansburg, Virginia, 24073
Consultants for Clinical Research, Inc.
Cincinnati, Ohio, 45219
Center for Gastroenterology
Decatur, Georgia, 30033
First Care Family Doctors South
Fayetteville, Arkansas, 72701
Digestive Liver Disease Specialists, Medical Group
Garden Grove, California, 92840
LeBauer Research Associates, PA
Greensboro, North Carolina, 27403
Medical Research Unlimited
Hialeah, Florida, 33013
Bethany Medical Center
High Point, North Carolina, 27262
Southern Clinical Research Consultants
Hollywood, Florida, 33021
Philip J. Beam Medical Center
Hollywood, Maryland, 20636
NationsMed Clinical Research
Houston, Texas, 77034
Clinical Trial Network
Houston, Texas, 77074
Houston Digestive Disease Clinic
Houston, Texas, 77090
Little Rock Diagnostic Clinic
Little Rock, Arkansas, 72205
Professionals for Clinical Research
Littleton, Colorado, 80120
Long Beach VA Medical Center
Long Beach, California, 90822
University of Louisville
Louisville, Kentucky, 40202
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201
Center for Digestive & Liver Diseases
Mexico, Missouri, 65265
Center for Advanced Research
Milwaukee, Wisconsin, 53215
Medical Research Institute
Nashville, Tennessee, 37205
United Medical Research
New Smyrna Beach, Florida, 32168
Simon Lichtiger, M.D.
New York, New York, 10128
Venture Research Institute, LLC
North Miami Beach, Florida, 33162
VA Medical Center, Northport
Northport, New York, 11768
Shore Health Group
Ocean City, New Jersey, 07712
Community Clinical Trials
Orange, California, 92868
Penninsula Research, Inc.
Ormond Beach, Florida, 32174
Advanced Gastroenterology Associates
Palm Harbor, Florida, 34684
Boice-Willis Clinic
Rocky Mount, North Carolina, 27804
Rider Research Group
San Francisco, California, 94117
John Jolley, M.D.
San Rafael, California, 94901
Lovelace Scientific Resources
Santa Ana, California, 92704
Santa Barbara Clinical Research
Santa Barbara, California, 93108
Lovelace Scientific Resources
Sarasota, Florida, 34233
Advent Clinical Research
Sarasota, Florida, 34239
Seattle Gastroenterology Associates
Seattle, Washington, 98133
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, 29681
Eastern Washington Clinical Research Center
Spokane, Washington, 99204
Spokane Digestive Disease Center
Spokane, Washington, 99204
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
VA Medical Center
Syracuse, New York, 13210
Digestive Disease Research Center
Tacoma, Washington, 98405
Cotton-O'Neil Digestive Health Center
Topeka, Kansas, 66606
Upstate Gastroenterology Associates, PC
Troy, New York, 12180
Oklahoma Gastroenterology Associates, LLC
Tulsa, Oklahoma, 74104
Avamar Center for Endoscopy
Warren, Ohio, 44484
Covenant Clinic
Waterloo, Iowa, 50702
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
About this study
Official title: A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP]) in participants with ulcerative colitis currently in remission.
Read the detailed description
This is a Phase 3, multicenter, open-label, treatment extension study evaluating the long-term safety and tolerability of eMG given once daily (QD) in participants who successfully participated in a double-blind lead-in study (MPUC3003 [NCT00744016 ] or MPUC3004 [NCT00767728 ]) or new participants who are currently in remission from symptoms of ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Encapsulated Mesalamine Granules (eMG)
- Keywords
- UC, Ulcerative colitis, Inflammatory bowel disease, IBD
- 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.
Encapsulated Mesalamine Granules (eMG)Drug
Also called Mesalamine pellets
eMG capsules will be administered per dose and schedule specified in the arm.
| Study group | Role | What they receive |
|---|---|---|
| Encapsulated Mesalamine Granules (eMG) | Experimental | Participants will receive eMG 1.5 grams (4 capsules of eMG 0.375 grams each) QD orally in the morning for up to 24 months. Receives: Drug: Encapsulated Mesalamine Granules (eMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any event with a start date occurring on or after treatment Day 1 or, if pre-existing, worsening after treatment Day 1. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline (Day 1) up to follow-up (24.5 months)
Number of Participants Who Prematurely Discontinued Treatment
Number of participants who prematurely discontinued treatment due to any reason were reported.
Measured: Baseline up to Month 24
Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities
Criteria for potentially clinically significant abnormal hematology and blood chemistry values included: hemoglobin (grams/deciliter [g/dL]): <10 and ≥3 decrease, or >20; hematocrit (%): <30 and ≥10 decrease, or >60; platelets (*10^9 cells/liter): <100 or >700 (normal: 150-400); white blood cells (*10^9 cells/liter): <2.3 or >16.2 (normal: 3.5-11.1); alanine aminotransferase (units/liter [U/L]): ≥3 * upper limit of normal (ULN) (normal range 0-47 U/L); aspartate aminotransferase (U/L): ≥3 * ULN (normal range 0-37 U/L); total bilirubin (micromoles/liter [µmol/L]): >2 times; and calcium creatinine clearance (milliliters/minute [mL/min]): ≤50.
Measured: Baseline up to follow-up (24.5 months)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight.
Measured: Baseline, up to follow-up visit (Month 24.5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study start22 Dec 2005
- Primary completion5 May 2008
- Study completion5 May 2008
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 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lindsey Mathew, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326209
- Sponsor's protocol ID
- MPUC3005
- Status last verified
- Oct 2019
- First submitted
- 12 May 2006
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lichtenstein 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 26563167
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation
- ClinicalTrials.gov ID
- NCT00326209
- Acronym / sponsor ID
- MPUC3005
- Conditions
- Ulcerative Colitis
- Keywords
- UC, Ulcerative colitis, Inflammatory bowel disease, IBD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2005 (actual)
- Primary completion
- 5 May 2008 (actual)
- Study completion
- 5 May 2008 (actual)
- First posted
- 16 May 2006 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP]) in participants with ulcerative colitis currently in remission.
Detailed description
This is a Phase 3, multicenter, open-label, treatment extension study evaluating the long-term safety and tolerability of eMG given once daily (QD) in participants who successfully participated in a double-blind lead-in study (MPUC3003 [NCT00744016 ] or MPUC3004 [NCT00767728 ]) or new participants who are currently in remission from symptoms of ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Encapsulated Mesalamine Granules (eMG) | Experimental | Drug: Encapsulated Mesalamine Granules (eMG)Participants will receive eMG 1.5 grams (4 capsules of eMG 0.375 grams each) QD orally in the morning for up to 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities.
- Participant has successfully participated in a previous MP clinical study per investigator's discretion with successful participation minimally defined as compliant with study-related procedures and study drug dosing schedule in the previous study and did not discontinue from the previous study due to study drug-related AE(s) or if new participants:
- Non-childbearing potential (that is; physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses); or childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following:
- The investigator is responsible for determining whether the participant has adequate birth control for study participation.
- Participant and investigator consider there is the potential for benefit to the participant with MP treatment.
Key exclusion criteria (9 listed)
- Participant has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
- Participant has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
- Participant has an abnormal clinical lab result which in the opinion of the investigator is significant enough to prevent participant's enrollment in the study.
- Participant or participant's parents are known to have phenylketonuria.
- Participant has participated in an investigational drug or device study within the 30 days prior to study screening.
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 |
|---|---|---|
| Encapsulated Mesalamine Granules (eMG)Also: Mesalamine pelletseMG capsules will be administered per dose and schedule specified in the arm. | Drug | Encapsulated Mesalamine Granules (eMG) |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline (Day 1) up to follow-up (24.5 months)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any event with a start date occurring on or after treatment Day 1 or, if pre-existing, worsening after treatment Day 1. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Number of Participants Who Prematurely Discontinued Treatment
Time frame: Baseline up to Month 24
Number of participants who prematurely discontinued treatment due to any reason were reported.
Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities
Time frame: Baseline up to follow-up (24.5 months)
Criteria for potentially clinically significant abnormal hematology and blood chemistry values included: hemoglobin (grams/deciliter [g/dL]): <10 and ≥3 decrease, or >20; hematocrit (%): <30 and ≥10 decrease, or >60; platelets (*10^9 cells/liter): <100 or >700 (normal: 150-400); white blood cells (*10^9 cells/liter): <2.3 or >16.2 (normal: 3.5-11.1); alanine aminotransferase (units/liter [U/L]): ≥3 * upper limit of normal (ULN) (normal range 0-47 U/L); aspartate aminotransferase (U/L): ≥3 * ULN (normal range 0-37 U/L); total bilirubin (micromoles/liter [µmol/L]): >2 times; and calcium creatinine clearance (milliliters/minute [mL/min]): ≤50.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline, up to follow-up visit (Month 24.5)
Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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.
Lindsey Mathew study director
Bausch Health Americas, Inc.
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Encapsulated Mesalamine Granules (eMG) in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 61 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 15 inclusion and 9 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 1 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 61 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. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2019). 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline (Day 1) up to follow-up (24.5 months)). The study lists 4 primary outcomes in all. 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 NCT00326209, 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 1 Nov 2019.