A double-blind, randomised, crossover study of two doses of a single-tablet
combination of ibuprofen/paracetamol and placebo for primary dysmenorrhoea.
Author(s): Eccles R, Holbrook A, Jawad M.
Affiliation(s): Common Cold Centre and Healthcare Clinical Trials, Cardiff School of Biosciences,
Cardiff University, Cardiff, UK. asharma@boisekidney.com
Publication date & source: 2010, Curr Med Res Opin. , 26(11):2689-99
OBJECTIVES: Efficacy of pain relief may potentially be enhanced by combining two
or more analgesics with different mechanisms of action. The objective of this
study was to assess the efficacy and tolerability of a novel single-tablet
combination of ibuprofen and paracetamol compared with placebo in females
experiencing moderate-to-severe pain due to primary dysmenorrhoea, a prevalent,
recurrent condition characterised by pain at the time of menses.
METHODS: This was a phase II/III, double-blind, randomised, cross-over,
single-dose study in 94 women with moderate-to-severe dysmenorrhoea, examining
the efficacy and tolerability of one or two tablets of a single-tablet
combination of ibuprofen 200 mg/paracetamol 500 mg compared with placebo.
CLINICAL TRIAL REGISTRATION: ISRCTN42521357
RESULTS: Total pain relief over 6 hours post-dose (TOTPAR(0-6h)) was
significantly greater following administration of two tablets of the
single-tablet combination of ibuprofen 200 mg/paracetamol 500 mg compared with
placebo (LS means: 2.35, 1.85, respectively; p = 0.0001) and approached
significance for one tablet (LS mean: 2.10; p = 0.054). Statistically superior
pain relief and reductions in pain intensity were achieved from 2 hours and 90
minutes post-dose, respectively, with the higher dose combination, and from 4
hours with the lower dose combination compared with placebo. Overall
effectiveness (sum of pain intensity difference and pain relief score [SPRID]
over 6 hours) were statistically superior to placebo for both one and two tablets
of the ibuprofen/paracetamol combination (p = 0.0011 and p = 0.03, respectively).
Both dose combinations were well-tolerated. Adverse events were minor and their
frequency and nature did not differ with either treatment compared with placebo.
CONCLUSIONS: One or two tablets of a single-tablet combination of ibuprofen 200
mg/paracetamol 500 mg is well-tolerated and provides superior analgesic efficacy
to placebo in patients with primary dysmenorrhoea.
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