Fg. Mcmahon et al., CONTROLLED-RELEASE DOSAGE FORMS AND GASTROINTESTINAL BLOOD-LOSS - 4 CLINICAL-STUDIES, International journal of pharmaceutics, 91(1), 1993, pp. 75-84
Four clinical studies were conducted to assess gastrointestinal (GI) b
lood loss during use of the OROS(R) dosage form. These were open-label
, randomized, parallel studies of 176 healthy volunteers 18-78 years o
f age. Blood loss was measured using the Cr-51 red blood cell tagging
method and stool guaiac tests. GI blood loss from a drug associated wi
th GI irritation, indomethacin [as OROS (sodium indomethacin) or as im
mediate-release indomethacin], was greater than that from lactose plac
ebo but less than that from aspirin. GI blood loss following ingestion
of the OROS dosage forms containing cold/allergy drugs - a combinatio
n of pseudoephedrine hydrochloride and brompheniramine maleate, chlorp
heniramine maleate, or pseudoephedrine hydrochloride - was statistical
ly indistinguishable from that of marketed reference slow-release cold
/allergy products or placebos. Blood loss in volunteers 50 years of ag
e or older was similar during use of OROS (mannitol) placebo or oral l
actose placebo tablets. Baseline GI blood loss in all four studies was
age-invariant. In these studies, GI blood loss, when present, was ass
ociated with specific drugs, aspirin and indomethacin, and not with a
particular OROS dosage form.