Efficacy of dosing and re-dosing of two oral fixed combinations of indomethacin, prochlorperazine and caffeine compared with oral sumatriptan in the acute treatment of multiple migraine attacks: A double-blind, double-dummy, randomised, parallel group, multicentre study

G. Sandrini, R. Cerbo, E. Del Bene, A. Ferrari, S. Genco, I. Grazioli, P. Martelletti, G. Nappi, L. Pinessi, P. Sarchielli, P. Tamburro, C. Uslenghi, G. Zanchin

Research output: Contribution to journalArticle

Abstract

Aims and methods: In this double-blind, double-dummy, randomised, parallel group, multicentre study, the efficacy of dosing and re-dosing of a fixed combination of indomethacin, prochlorperazine and caffeine (Indoprocaf) was compared with encapsulated sumatriptan in the acute treatment of two migraine attacks. Additionally, in the group taking Indoprocaf, two different oral formulations were tested: effervescent tablets and encapsulated coated tablets. Results: Of 297 patients randomised (150 assigned to Indoprocaf and 147 to sumatriptan), 281 were included in the intention-to-treat efficacy analysis. The initial dosing of Indoprocaf and sumatriptan was similarly effective with pain-free rates higher than 30% (95% CI of odds-ratio: 0.57-1.28) and headache relief rates of about 60% (95% CI of odds-ratio: 0.82-1.84) with both the drugs. The efficacy of re-dosing of Indoprocaf as rescue medication was more effective than that of sumatriptan with pain-free values of 47% vs. 27% in the total attacks with a statistically significant difference in the first migraine attack in favour of Indoprocaf. The efficacy of re-dosing to treat a recurrence/relapse was very high without differences between the drugs (pain-free: 60% with Indoprocaf and 50% with sumatriptan in the total attacks). Indoprocaf and sumatriptan were well-tolerated. Conclusion: The study demonstrated that the efficacy of the initial dosing of Indoprocaf was not higher than that of sumatriptan, but that the strategy to use the lowest effective dose as soon as the headache occurred, followed by a second dose if the headache has not relieved or to treat a relapse, was very effective, especially with Indoprocaf.

Original languageEnglish
Pages (from-to)1256-1269
Number of pages14
JournalInternational Journal of Clinical Practice
Volume61
Issue number8
DOIs
Publication statusPublished - Aug 2007

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Prochlorperazine
Sumatriptan
Caffeine
Migraine Disorders
Indomethacin
Multicenter Studies
Headache
Therapeutics
Recurrence
Tablets
Odds Ratio
Intention to Treat Analysis
Double-Blind Method
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Medicine(all)

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Efficacy of dosing and re-dosing of two oral fixed combinations of indomethacin, prochlorperazine and caffeine compared with oral sumatriptan in the acute treatment of multiple migraine attacks : A double-blind, double-dummy, randomised, parallel group, multicentre study. / Sandrini, G.; Cerbo, R.; Del Bene, E.; Ferrari, A.; Genco, S.; Grazioli, I.; Martelletti, P.; Nappi, G.; Pinessi, L.; Sarchielli, P.; Tamburro, P.; Uslenghi, C.; Zanchin, G.

In: International Journal of Clinical Practice, Vol. 61, No. 8, 08.2007, p. 1256-1269.

Research output: Contribution to journalArticle

Sandrini, G. ; Cerbo, R. ; Del Bene, E. ; Ferrari, A. ; Genco, S. ; Grazioli, I. ; Martelletti, P. ; Nappi, G. ; Pinessi, L. ; Sarchielli, P. ; Tamburro, P. ; Uslenghi, C. ; Zanchin, G. / Efficacy of dosing and re-dosing of two oral fixed combinations of indomethacin, prochlorperazine and caffeine compared with oral sumatriptan in the acute treatment of multiple migraine attacks : A double-blind, double-dummy, randomised, parallel group, multicentre study. In: International Journal of Clinical Practice. 2007 ; Vol. 61, No. 8. pp. 1256-1269.
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abstract = "Aims and methods: In this double-blind, double-dummy, randomised, parallel group, multicentre study, the efficacy of dosing and re-dosing of a fixed combination of indomethacin, prochlorperazine and caffeine (Indoprocaf) was compared with encapsulated sumatriptan in the acute treatment of two migraine attacks. Additionally, in the group taking Indoprocaf, two different oral formulations were tested: effervescent tablets and encapsulated coated tablets. Results: Of 297 patients randomised (150 assigned to Indoprocaf and 147 to sumatriptan), 281 were included in the intention-to-treat efficacy analysis. The initial dosing of Indoprocaf and sumatriptan was similarly effective with pain-free rates higher than 30{\%} (95{\%} CI of odds-ratio: 0.57-1.28) and headache relief rates of about 60{\%} (95{\%} CI of odds-ratio: 0.82-1.84) with both the drugs. The efficacy of re-dosing of Indoprocaf as rescue medication was more effective than that of sumatriptan with pain-free values of 47{\%} vs. 27{\%} in the total attacks with a statistically significant difference in the first migraine attack in favour of Indoprocaf. The efficacy of re-dosing to treat a recurrence/relapse was very high without differences between the drugs (pain-free: 60{\%} with Indoprocaf and 50{\%} with sumatriptan in the total attacks). Indoprocaf and sumatriptan were well-tolerated. Conclusion: The study demonstrated that the efficacy of the initial dosing of Indoprocaf was not higher than that of sumatriptan, but that the strategy to use the lowest effective dose as soon as the headache occurred, followed by a second dose if the headache has not relieved or to treat a relapse, was very effective, especially with Indoprocaf.",
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T1 - Efficacy of dosing and re-dosing of two oral fixed combinations of indomethacin, prochlorperazine and caffeine compared with oral sumatriptan in the acute treatment of multiple migraine attacks

T2 - A double-blind, double-dummy, randomised, parallel group, multicentre study

AU - Sandrini, G.

AU - Cerbo, R.

AU - Del Bene, E.

AU - Ferrari, A.

AU - Genco, S.

AU - Grazioli, I.

AU - Martelletti, P.

AU - Nappi, G.

AU - Pinessi, L.

AU - Sarchielli, P.

AU - Tamburro, P.

AU - Uslenghi, C.

AU - Zanchin, G.

PY - 2007/8

Y1 - 2007/8

N2 - Aims and methods: In this double-blind, double-dummy, randomised, parallel group, multicentre study, the efficacy of dosing and re-dosing of a fixed combination of indomethacin, prochlorperazine and caffeine (Indoprocaf) was compared with encapsulated sumatriptan in the acute treatment of two migraine attacks. Additionally, in the group taking Indoprocaf, two different oral formulations were tested: effervescent tablets and encapsulated coated tablets. Results: Of 297 patients randomised (150 assigned to Indoprocaf and 147 to sumatriptan), 281 were included in the intention-to-treat efficacy analysis. The initial dosing of Indoprocaf and sumatriptan was similarly effective with pain-free rates higher than 30% (95% CI of odds-ratio: 0.57-1.28) and headache relief rates of about 60% (95% CI of odds-ratio: 0.82-1.84) with both the drugs. The efficacy of re-dosing of Indoprocaf as rescue medication was more effective than that of sumatriptan with pain-free values of 47% vs. 27% in the total attacks with a statistically significant difference in the first migraine attack in favour of Indoprocaf. The efficacy of re-dosing to treat a recurrence/relapse was very high without differences between the drugs (pain-free: 60% with Indoprocaf and 50% with sumatriptan in the total attacks). Indoprocaf and sumatriptan were well-tolerated. Conclusion: The study demonstrated that the efficacy of the initial dosing of Indoprocaf was not higher than that of sumatriptan, but that the strategy to use the lowest effective dose as soon as the headache occurred, followed by a second dose if the headache has not relieved or to treat a relapse, was very effective, especially with Indoprocaf.

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