Dysmenorrhoea Efficacy Study

• Research type

  Research Study

• Full title

  A double-blind, randomised crossover, single dose, single centre, study examining the analgesic efficacy and tolerability of fixed-dose combinations of ibuprofen 200 mg and acetaminophen 500 mg, ibuprofen 400 mg and acetaminophen 1,000 mg and placebo in primary dysmenorrhoea.

• IRAS ID

  12452

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Limited

• Eudract number

  2008-006762-29

• ISRCTN Number

  1

• Research summary

  Paracetamol and ibuprofen are both used to treat pain. Studies on dental pain indicate that a combination tablet of paracetamol and ibuprofen may be more effective than either medicine alone. The primary objective of this study is to assess the efficacy of a fixed dose combination tablet of 200 mg ibuprofen plus 500 mg acetaminophen (paracetamol), administered as one or two tablets (two tablets equivalent to 400 mg ibuprofen plus 1,000 mg acetaminophen(paracetamol)) in comparison to placebo among patients experiencing moderate to severe pain due to primary dysmenorrhoea (period pain), in terms of pain relief. The study will be conducted at Cardiff University.

• REC name

  Wales REC 2

• REC reference

  09/WSE02/7

• Date of REC Opinion

  16 Jan 2009

• REC opinion

  Favourable Opinion