Multiple Ascending Dose study - Naloxone SR for OIC

• Research type

  Research Study

• Full title

  A Multicenter, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability and Efficacy Study of Naloxone Sustained Release capsules in Subjects with Constipation due to Opioids taken for persistent Non-Cancer pain

• IRAS ID

  13076

• Sponsor organisation

  SLA Pharma UK Ltd

• Eudract number

  2009-009377-10

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Opioids are effective in managing acute and chronic pain but one of their most common and distressing adverse effects is constipation (often referred to as Opioid Induced Constipation OIC) in a substantial proportion of patients. Complications associated with OIC include, faecal impaction and spurious diarrhea; pseudo-obstruction of the bowel; and possible interference with drug administration and absorption. Because current therapy for constipation is non-specific and the long-term effects of chronic bowel stimulant use are not known, there is a need for better, more specific treatment. Because constipation appears to be primarily a peripheral opioid effect, it is theoretically possible to separate this adverse effect from the central analgesic effectsNaloxone SR capsules contain the active naloxone hydrochloride (an opioid antagonist). The active is embedded within a waxy matrix to enable prolonged release. The prolonged release matrix itself is encapsulated and coated to delay release of the active to the distal small bowel/colon. The colon is believed to be where the major mechanism for the effect of opioids, on bowel function, occurs. naloxone sustained release (SR) capsules are being developed by SLA Pharma as a proposed treatment, administered orally, for Opioid Induced constipation (OIC). The objectives of this trial are to identify the optimum dosage regime of Nalcol based on tolerability level, to improve spontaneous bowel movement frequency, and relieve GI symptoms, in patients suffering with OIC. Doses will be escalated in cohorts providing no serious tolerability concerns have occurred in the preceding cohort

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/33

• Date of REC Opinion

  27 May 2009

• REC opinion

  Further Information Favourable Opinion