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Efficacy and Safety...
Efficacy and Safety of PPC-5650 on Experimental Rectal Pain in Patients with Irritable Bowel Syndrome.
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Nielsen, Lecia Møller (författare)
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Olesen, Anne Estrup (författare)
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Andresen, Trine (författare)
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- Simrén, Magnus, 1966 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Centrum för personcentrerad vård vid Göteborgs universitet (GPCC),Institute of Medicine, Department of Internal Medicine and Clinical Nutrition,University of Gothenburg Centre for person-centred care (GPCC)
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- Törnblom, Hans, 1966 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition
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Drewes, Asbjørn Mohr (författare)
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(creator_code:org_t)
- 2014-09-08
- 2015
- Engelska.
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Ingår i: Basic & clinical pharmacology & toxicology. - : Wiley. - 1742-7843 .- 1742-7835. ; 116:2, s. 140-145
- Relaterad länk:
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https://onlinelibrar...
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- PPC-5650 is a new pharmacological agent that can modulate acid-sensing ion channel activity, leading to a reduction in the pain signal under up-regulated conditions. The non-clinical programme for PPC-5650 supported a role for this novel agent in the treatment of pain in patients with irritable bowel syndrome (IBS). In patients with IBS, the aims of the study were: (1) to assess the efficacy of a single bolus of PPC-5650 locally applied in the rectum using multi-modal stimulations of the recto sigmoid and (2) to assess the safety profile of PPC-5650. The study was a randomized, double-blind, placebo-controlled, cross-over trial in patients with IBS, excluding females of child-bearing potential. The study consisted of a training visit, study visit 1 and 2 and a follow-up visit. Rectosigmoid electrical, thermal and mechanical stimulations were performed, pain perception was rated on a pain intensity scale and referred pain areas were assessed. All adverse events were registered. Twenty-five patients with IBS were enrolled and completed the study (9 women and 16 men; mean age 50.4±12.7years). No effects of the study drug were found on any of the rectal stimulations or for referred pain areas (all p>0.05). No significant or clinically relevant treatment-related differences were seen for the laboratory safety variables or any other reported adverse event. In conclusion, in patients with IBS on rectal sensitivity to multi-modal stimulations, PPC-5650 did not produce efficacy relative to placebo. The overall safety and tolerability of PPC-5650 was acceptable.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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