Lubiprostone not effective for paediatric functional constipation
Lubiprostone does not appear to have any favourable effect in the treatment of paediatric functional constipation (PFC), although the drug has a safety profile similar to that reported in adults, as shown in a phase III study.
The study consisted of two parts. In the first part, a total of 606 patients with PFC (aged 6–17 years) were randomized to receive lubiprostone at either 12 or 24 mcg BID (n=404) or placebo (n=202) for 12 weeks. The second part was an open-label extension of part 1.
In both parts, lubiprostone doses were based on patient weight. Efficacy was assessed solely based on the results of the first part, with a primary endpoint of overall spontaneous bowel movement (SBM) response (increase of ≥1 SBM/week vs baseline and ≥3 SBMs/week for ≥9 weeks, including 3 of the final 4 weeks).
Results revealed no statistically significant difference in overall SBM response rate between the lubiprostone and placebo groups. The endpoint was achieved in 18.5 percent of patients in the active treatment group versus 14.4 percent of those who received placebo (p=0.2245).
Both the 12- and 24-mcg BID doses of lubiprostone were well tolerated in the double-blind and extension parts. The safety profile was consistent with that observed in adult studies.