drugset / Trial / NCT01094808
Pregabalin and Colonic Function
Phase 4
Completed
62 enrolled
Mayo Clinic
National Center for Research Resources (NCRR) · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupQuadruple-blind
Summary
This study is being done to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals. The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds, decreases sensation ratings, and increases compliance in response to balloon distension in the colon; 2) pregabalin reduces colonic phasic and tonic motility in response to a standardized meal; and 3) sensation ratings are lower with higher colonic compliance.
Timeline
- Start
- 2010-03
- Primary completion
- 2011-02
- Completion
- 2011-02
Publications
- Results Iturrino J, Camilleri M, Busciglio I, Burton D, Zinsmeister AR. Effect of the alpha2delta ligand, pregabalin, on colonic sensory and motor functions in healthy adults. Am J Physiol Gastrointest Liver Physiol. 2011 Aug;301(2):G377-84. doi: 10.1152/ajpgi.00085.2011. Epub 2011 May 19.
- Iturrino J, Camilleri M, Busciglio I, Burton D, Zinsmeister AR. Sensations of gas and pain and their relationship with compliance during distension in human colon. Neurogastroenterol Motil. 2012 Jul;24(7):646-51, e275. doi: 10.1111/j.1365-2982.2012.01901.x. Epub 2012 Mar 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pregabalin | Small molecule | 75 mg | Oral |
| Subject | Pregabalin | Small molecule | 200 mg | Oral |
Indications
No indication recorded.