A double-blind trial of carbenoxolone sodium capsules in the treatment of duodenal ulcer.

A controlled trial of carbenoxolone sodium positioned-release capsules (Duogastrone) was carried out on a randomized series of 100 unselected male Service personnel with symptoms of active duodenal ulceration and supporting radiological evidence. Fifty-seven patients completed the trial, 29 in the carbenoxolone group and 28 in the control group. The carbenoxolone group was given capsules containing 50 mg carbenoxolone four times a day for 12 weeks while the controls received a capsule identical in every respect except that it did not contain carbenoxolone. All patients were assessed at fortnightly intervals and had clinical and radiological reassessments three and six months after commencing treatment. Review at three months and at six months revealed a slight but clinically insignificant trend in favour of the carbenoxolone group. As a corollary to this controlled trial, those patients (38 in all) who did not have an early remission of symptoms were removed from the trial and placed on capsules known to contain carbenoxolone. Subsequently these patients did not show an advantage for carbenoxolone.

RCT Entities:   Population Interventions Outcomes