Trial · NCT00326209
Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
NCT00326209, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2019-11-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission. Trials, record NCT00326209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00326209
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
- NCT number
- NCT00326209
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 393 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Ulcerative Colitis
- Interventions
- Encapsulated Mesalamine Granules (eMG)
- First posted
- 2006-05-16
- Last updated
- 2019-11-01
- Results first posted
- 2019-11-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. |
| Primary | Number of Participants Who Prematurely Discontinued Treatment | Baseline up to Month 24 | Number of participants who prematurely discontinued treatment due to any reason were reported. |
| Primary | Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | 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. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline, up to follow-up visit (Month 24.5) | Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline (Day 1) up to follow-up (24.5 months) | Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Prematurely Discontinued Treatment | Baseline up to Month 24 | Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | Baseline up to follow-up (24.5 months) | Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline, up to follow-up visit (Month 24.5) | Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Encapsulated Mesalamine Granules (eMG) | 280 | Participants | ||
| Number of Participants Who Prematurely Discontinued Treatment | Encapsulated Mesalamine Granules (eMG) | 282 | Participants | ||
| Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | Encapsulated Mesalamine Granules (eMG) | Hemoglobin (g/dL) | 8 | Participants | |
| Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | Encapsulated Mesalamine Granules (eMG) | Hematocrit (%) | 7 | Participants | |
| Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | Encapsulated Mesalamine Granules (eMG) | Platelets (*10^9 cells/L) | 5 | Participants | |
| Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | Encapsulated Mesalamine Granules (eMG) | White blood cells (*10^9 cells/L) | 13 | Participants | |
| Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | Encapsulated Mesalamine Granules (eMG) | Alanine aminotransferase (U/L) | 3 | Participants | |
| Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | Encapsulated Mesalamine Granules (eMG) | Aspartate aminotransferase (U/L) | 3 | Participants | |
| Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | Encapsulated Mesalamine Granules (eMG) | Total bilirubin (µmol/L) | 6 | Participants | |
| Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities | Encapsulated Mesalamine Granules (eMG) | Calcium creatinine clearance (mL/min) | 2 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Encapsulated Mesalamine Granules (eMG) | 393 | |
| Overall Study | Safety Population | Encapsulated Mesalamine Granules (eMG) | 388 | |
| Overall Study | COMPLETED | Encapsulated Mesalamine Granules (eMG) | 111 | |
| Overall Study | NOT COMPLETED | Encapsulated Mesalamine Granules (eMG) | 282 |
Source ClinicalTrials.gov
Adverse events49
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Encapsulated Mesalamine Granules (eMG) | 42 | 388 | |
| other | Abdominal Pain | Gastrointestinal disorders | Encapsulated Mesalamine Granules (eMG) | 31 | 388 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Encapsulated Mesalamine Granules (eMG) | 24 | 388 | |
| other | Nausea | Gastrointestinal disorders | Encapsulated Mesalamine Granules (eMG) | 22 | 388 | |
| other | Constipation | Gastrointestinal disorders | Encapsulated Mesalamine Granules (eMG) | 17 | 388 | |
| other | Dyspepsia | Gastrointestinal disorders | Encapsulated Mesalamine Granules (eMG) | 16 | 388 | |
| other | Haemorrhoids | General disorders | Encapsulated Mesalamine Granules (eMG) | 16 | 388 | |
| other | Vomiting | Gastrointestinal disorders | Encapsulated Mesalamine Granules (eMG) | 16 | 388 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Encapsulated Mesalamine Granules (eMG) | 14 | 388 | |
| other | Abdominal distension | Gastrointestinal disorders | Encapsulated Mesalamine Granules (eMG) | 13 | 388 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Encapsulated Mesalamine Granules (eMG) | ||
| Total, other adverse events | Encapsulated Mesalamine Granules (eMG) | 280 | 388 |
| Total, serious adverse events | Encapsulated Mesalamine Granules (eMG) | 28 | 388 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26563167 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00326209
GET https://conductscience.org/api/trials/v1/NCT00326209/events?page=2