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Nicotinic Acetylcholine Receptor Partial Agonist
Varenicline for Irritable Bowel Syndrome
Rochester, MN
Phase 1
Recruiting
Led By Michael Camilleri
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Irritable bowel syndrome with pain, but no constipation (IBS-D, IBS-M, or IBS-U)
Participants will be 18-70 years of age
Must not have
Dementia, unprovoked seizure history, seizure disorder
Severe hepatic or renal impairment, such as baseline AST or ALT >2.5 X upper normal limit or end-stage renal disease with estimated glomerular filtration rate or creatinine clearance <15 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see how a medication called varenicline affects the way the rectum senses things in people with irritable bowel syndrome and chronic abdominal pain.
See full description
Who is the study for?
Adults aged 18-70 with Irritable Bowel Syndrome (IBS) that includes pain but not constipation can join this study. They shouldn't have a recent history of substance abuse, be pregnant or unstable medically, and should not have had changes in antidepressant or pain medications recently.Check my eligibility
What is being tested?
The trial is testing Varenicline to see if it affects how people with IBS feel pain in their gut. Participants will undergo tests where their rectal sensation is measured after taking the medication.See study design
What are the potential side effects?
While the side effects specific to this trial are not listed, common side effects of Varenicline include nausea, sleep problems, constipation, gas and vomiting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have IBS with pain but no constipation.
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I am between 18 and 70 years old.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have dementia or a history of unprovoked seizures.
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I do not have severe liver or kidney problems.
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I am not taking strong medication that affects liver enzymes.
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I have been diagnosed with moderate to severe depression.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rectal compliance
Rectal sensation ratings during random order, graded phasic distensions
Rectal sensation thresholds during ascending method of limits
Secondary study objectives
Safety/adverse effects
Side effects data
From 2022 Phase 4 trial • 39 Patients • NCT0401128050%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Agitation
21%
Depression
21%
Headache
14%
Heartburn
14%
Allergies
14%
Cold
14%
Back Pain
7%
Confusion
7%
Aggression
7%
Panic
7%
Stomach Pain
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Sinusitis
7%
Angina
7%
Increased Blood Pressure
7%
Palpitations
7%
Cellulitis
7%
Rash
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VareniciclineExperimental Treatment1 Intervention
Varenicline is a α4β2 and α6β2 partial agonist.
Varenicline (Chantix) is an FDA-approved partial agonist at α4β2 and α6β2 nAChRs with documented efficacy in the management of chronic pain associated with opioid withdrawal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Find a Location
Closest Location:Mayo Clinic in Rochester· Rochester, MN· 562 miles
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,413 Previous Clinical Trials
3,208,815 Total Patients Enrolled
27 Trials studying Irritable Bowel Syndrome
5,183 Patients Enrolled for Irritable Bowel Syndrome
Michael CamilleriPrincipal InvestigatorMayo Clinic
6 Previous Clinical Trials
147 Total Patients Enrolled
2 Trials studying Irritable Bowel Syndrome
54 Patients Enrolled for Irritable Bowel Syndrome