Varenicline in the Treatment of Visceral Sensation: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Rectal compliance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be 18-70 years of age
- •Irritable bowel syndrome with pain, but no constipation [that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)]
排除标准
- •Diagnosis of moderate-severe depression as per HADS>8
- •Alcohol or illicit substance dependence or abuse in the past 12 months
- •Dementia, unprovoked seizure history, seizure disorder
- •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)
- •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
- •Medically unstable
- •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
- •Concomitant use of strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers
- •Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
- •Eligibility last updated 12/27/
- •Questions regarding updates should be directed to the study team contact.
研究组 & 干预措施
Varenicicline
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
干预措施: Varenicline (Drug)
结局指标
主要结局
Rectal compliance
时间窗: 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
时间窗: 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
时间窗: Comparison on day 8 of vareniciline treatment compared to baseline
Report of rectal sensation during balloon distensions
次要结局
- Safety/adverse effects(8 days)
研究者
Michael Camilleri, MD
Principal Investigator
Mayo Clinic