drugset / Trial / NCT00755573
Pain and Chronic Pancreatitis - Clinical End Experimental Studies
Phase 2/3
Completed
64 enrolled
Aalborg University Hospital
Radboud University Medical Center · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim of the study is to investigate the effect of pregabalin in pain resulting from chronic pancreatitis. The effect will be investigated by means of questionnaires concerning the daily experience of pain and the general quality of life. Furthermore the patients will be invited to participate in experimental testing with a multimodal pain model. The experimental testing will include stimulation of the skin, muscle and visceral tissue. The results from the experimental part of the study may help us to understand the mechanisms of action of pregabalin in this patient population.
Timeline
- Start
- 2008-10
- Primary completion
- 2010-05
- Completion
- 2010-05
Publications
- Bouwense SA, Olesen SS, Drewes AM, Poley JW, van Goor H, Wilder-Smith OH. Effects of pregabalin on central sensitization in patients with chronic pancreatitis in a randomized, controlled trial. PLoS One. 2012;7(8):e42096. doi: 10.1371/journal.pone.0042096. Epub 2012 Aug 6.
- Olesen SS, Graversen C, Olesen AE, Frokjaer JB, Wilder-Smith O, van Goor H, Valeriani M, Drewes AM. Randomised clinical trial: pregabalin attenuates experimental visceral pain through sub-cortical mechanisms in patients with painful chronic pancreatitis. Aliment Pharmacol Ther. 2011 Oct;34(8):878-87. doi: 10.1111/j.1365-2036.2011.04802.x. Epub 2011 Aug 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pregabalin | Small molecule | 300 mg | — |
| Comparator | Pregabalin | Small molecule | 600 mg | — |