Irritable Bowel Syndrome
Conditions
Keywords
IBS, pain
Brief summary
The purpose of this study is to evaluate the effect of varenicline on rectal sensation, based on ascending method of limits and on graded rapid phasic distensions in participants with non-constipation IBS and chronic abdominal pain.
Interventions
DRUGVarenicline
Initial, 0.5 mg orally once daily for 3 days, then 0.5 mg every 12 hours on days 4 through 7, and then 1 mg in morning of day 8. Medication is taken after eating and with a full glass of water.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
To evaluate the effect of varenicline on rectal sensation, based on ascending method of limits and on graded rapid phasic distensions in participants with non-constipation IBS and chronic abdominal pain
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Participants will be 18-70 years of age 2. Irritable bowel syndrome with pain, but no constipation \[that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)\]
Exclusion criteria
1. Diagnosis of moderate-severe depression as per HADS>8 2. Alcohol or illicit substance dependence or abuse in the past 12 months 3. Dementia, unprovoked seizure history, seizure disorder 4. Pregnancy (all women of childbearing potential will be required to have a negative pregnancy test prior to initiation, and will be on a highly effective method of contraception, as detailed in the consent form) 5. Significant change or increase in antidepressant or pain medications within the last four weeks; significant change in primary treatment interventions for pain in the past four weeks 6. Medically unstable 7. 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 8. Concomitant use of strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rectal compliance | Comparison on day 8 of vareniciline treatment compared to baseline | Pressure-volume relationship of rectum during balloon distension |
| Rectal sensation thresholds during ascending method of limits | Comparison on day 8 of vareniciline treatment compared to baseline | Report of rectal sensation during balloon distension 0-44mmHg |
| Rectal sensation ratings during random order, graded phasic distensions | Comparison on day 8 of vareniciline treatment compared to baseline | Report of rectal sensation during balloon distensions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety/adverse effects | 8 days | Safety/adverse effects during administration of varenicicline |
Countries
United States
Outcome results
None listed