A study to evaluate the effect and tolerability of laxatives (medicines against constipation) for the reversal of constipation caused by opioids (medicines against pain)

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-000180-81

Femme et Homme

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Extrait

Primary Objective •To assess the effect of SLT on the frequency of soft (stool of type 3, 4 or 5 on the Bristol Stool Form Scale (BSFS)) complete bowel movements (SCBMs) per week in subjects taking World Health Organisation (WHO) step II/III opioid analgesics at Visit 8 (change from baseline to the final visit)


Critère d'inclusion

  • Assess the effect and tolerability of standardised laxative therapy (SLT) for the reversal of opioid-induced constipation (OIC) in subjects suffering from malignant or non-malignant pain that requires around-the-clock opioid therapy