Irritable Bowel SyndromePhase 3MesalamineNCT01412372
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
A Phase 3 study testing Mesalamine in people with Irritable Bowel Syndrome, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Mesalamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to 22 Apr 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 18-75 years
- Rome III criteria for IBS
- Symptom onset after apparent acute gastroenteritis
- Symptoms of 6 months or greater duration
- Normal gross appearance of the colonic mucosa other than erythema
- Negative markers for celiac disease and inflammatory bowel disease
- Normal thyroid function and serum calcium
- Stable medication regimens for other medical conditions.
Who cannot join
- Age <18 or >75 years
- Previous diagnosis of or history compatible with IBS
- Constipation-predominant IBS.
- Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
- History of/or presence of malignancy
- Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic resection, paraplegia or quadriplegia. .
Show all 11Show fewer
- Current evidence of drug or alcohol abuse as judged by the investigator
- Allergy to mesalamine or aspirin
- Investigator perception of patient's inability to comply with the study protocol
- Unstable psychiatric disease
- Recent change in gastrointestinal medications
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.
Read the detailed description
This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial.
This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Mesalamine, Placebo
- Keywords
- Irritable Bowel Syndrome, Diarrhea, Mesalamine, Gastroenteritis, abdominal pain, hypersensitivity
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea, Gastroenteritis, Abdominal Pain, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
Also called Lialda
2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
PlaceboDrug
Also called Inactive drug
This is an inactive pill
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | This arm will include those who are randomized to the placebo Receives: Drug: Placebo |
| Mesalamine | Experimental | This arm is for subjects randomized to the study drug, Mesalamine Receives: Drug: Mesalamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period
BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period.
As measured by the IBS specific Quality of Life questionnaire which consists of 34 items scored on a scale of 0% to 100%, 0 being not at all and 100 being extremely.
Measured: Baseline and 8 weeks
Change in Average Bowel Frequency After 8-Week Treatment Period
Measured by the participant reported average number of daily bowel movements.
Measured: Baseline and 8 weeks
Change in Average Bowel Consistency Score After an 8 Week Treatment Period.
Measured using the Bristol Stool form scale 1-7, with 1 being the most formed and 7 the least formed.
Measured: Baseline and 8 weeks
Change in Average Abdominal Pain Score After an 8 Week Treatment Period
Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Measured: Baseline and 8 weeks
Change in Average Bloating Score After an 8 Week Treatment Period.
Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startJun 2010
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
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.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Shire Human Genetic Therapies, Inc.
- Responsible party
- Principal investigator, Ashok K. Tuteja, University of Utah
- Investigators
- Ashok Tuteja, Principal investigator, Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412372
- Sponsor's protocol ID
- 39402
- Acronym
- Mesalamine
- Status last verified
- Dec 2020
- First submitted
- 24 Jun 2011
- Last updated
- 31 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
- ClinicalTrials.gov ID
- NCT01412372
- Acronym / sponsor ID
- Mesalamine / 39402
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Diarrhea, Mesalamine, Gastroenteritis, abdominal pain, hypersensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Shire Human Genetic Therapies, Inc.
- Study start
- Jun 2010
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Posted 31 Dec 2020
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 evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.
Detailed description
This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial.
This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboThis arm will include those who are randomized to the placebo |
| Mesalamine | Experimental | Drug: MesalamineThis arm is for subjects randomized to the study drug, Mesalamine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women age 18-75 years
- Rome III criteria for IBS
- Symptom onset after apparent acute gastroenteritis
- Symptoms of 6 months or greater duration
- Normal gross appearance of the colonic mucosa other than erythema
Key exclusion criteria (11 listed)
- Age <18 or >75 years
- Previous diagnosis of or history compatible with IBS
- Constipation-predominant IBS.
- Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
- History of/or presence of malignancy
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 |
|---|---|---|
| MesalamineAlso: Lialda2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo | Drug | Mesalamine |
| PlaceboAlso: Inactive drugThis is an inactive pill | Drug | Placebo |
Primary outcome
Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period
Time frame: Baseline and 8 weeks
BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
5 secondary outcomes
Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period.
Time frame: Baseline and 8 weeks
Change in Average Bowel Frequency After 8-Week Treatment Period
Time frame: Baseline and 8 weeks
Change in Average Bowel Consistency Score After an 8 Week Treatment Period.
Time frame: Baseline and 8 weeks
Change in Average Abdominal Pain Score After an 8 Week Treatment Period
Time frame: Baseline and 8 weeks
Change in Average Bloating Score After an 8 Week Treatment Period.
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ashok Tuteja principal investigator
Gastroenterology
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 Mesalamine in people with Irritable Bowel Syndrome, run by University of Utah 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 8 inclusion and 11 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 31 Dec 2020. 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. 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 31 Dec 2020). 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?
Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period (time frame: Baseline and 8 weeks). 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 Dec 2020.