(duplicate) Diltiazem hydrochloride cream in anal fissure

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Diltiazem Hydrochloride Cream in Subjects with Anal Fissure

• IRAS ID

  9159

• Contact name

  Jonathan Lund

• Sponsor organisation

  S.L.A. Pharma (UK) Ltd

• Eudract number

  2008-005172-26

• ISRCTN Number

  N/A

• Research summary

  Anal fissure is a tear in the lining of the anal canal (back passage). It is extremely painful, especially during and immediately after opening of the bowels. The underlying cause is thought to be linked to excessive tension in the muscle (sphincter) that controls continence. Diltiazem is a muscle relaxant. Applied locally as a cream around the back passage, it reduces tension in the sphincter muscle. The study will determine the safety and effectiveness of diltiazem hydrochloride cream in reducing pain and promoting healing of the fissure

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  08/H1207/278

• Date of REC Opinion

  13 Feb 2009

• REC opinion

  Further Information Favourable Opinion