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This article was originally published in The Tan Sheet

Executive Summary

REQUA ASKS FDA FOR FEEDBACK MEETING TO DISCUSS ACTIVATED CHARCOAL PROTOCOL by the end of the year, according to the firm. Requa said it submitted a protocol to the agency on Nov. 1, but does not plan to begin the trial until the agency reviews the protocol, provided that an "OTC feedback" meeting can be scheduled in a reasonable amount of time. Requa also plans to petition FDA to delay the effective date of the OTC digestive aids final monograph once the trial commences so that the study results can be taken into account. Greenwich, Conn.-based Requa, which markets a line of activated charcoal-containing products for gastrointestinal distress, said the study could be completed within three-to-six months. In FDA's Oct. 21 final monograph for OTC digestive aids, the agency explained that "although data and information were submitted on activated charcoal, they were not sufficient to support monograph conditions" ("The Tan Sheet" Oct. 25, p. 15). Requa's 1991 petition requesting the ingredient's reclassification from Category III (data insufficient to permit classification) to Category I (safe and effective) was rejected by the agency. The monograph becomes effective in April. The proposed protocol is a double-blind, randomized, placebo- controlled, parallel design study with 85 volunteers receiving activated charcoal capsules and 85 receiving placebo. The study will measure the effectiveness of activated charcoal in decreasing gastrointestinal symptoms, which are defined by Requa as bloating/pressure/distention/fullness, or pain/cramping, and/or flatulence. Requa plans to include males and females between the ages of 21 and 65 who have a six-month history of once- or twice-weekly gastrointestinal discomfort following the ingestion of "certain gas-producing foods." Subjects qualifying for inclusion in the study must demonstrate during a "pre-test" that they develop "one or more" of the gastrointestinal distress symptoms defined by Requa "to a combined level of three or more." Subjects will be excluded if they demonstrate that they are a "responder to placebo medication," the protocol states. Those who qualify for inclusion in the study will return to the study site for the test meal after a five-to-seven-day "wash- out" period. Subjects will be randomly assigned to receive either the treatment (260 mg activated charcoal) or placebo (370 mg dextrose). Both groups will receive identical instructions, meals and treatment with identically packaged placebo. Each subject will ingest two capsules at the "first sign of discomfort" and two additional capsules after 30 minutes if symptoms persist until a total of eight capsules have been consumed. Symptoms of gastrointestinal distress will be recorded and compared to changes in symptoms, the amount of relief and time of relief. Participants who do not become symptomatic will not be randomized into the study. Interim analyses will be conducted when 30 and 60 subjects in each of the two groups complete the testing. "If these analyses indicate either no treatment effect, or a strong treatment effect, the sponsor may consider termination," the protocol explains. The test meal consists of two hot dogs in rolls prepared with sauerkraut, mustard and/or ketchup; an additional eight-ounce portion of sauerkraut; eight ounces (one cup) of baked beans prepared with one ounce of white onion; and one to two eight-ounce glasses of water. Participants will be instructed to alternate bites of hot dog followed by beans followed by sauerkraut. Study participants are expected to adhere to a "bland" diet regimen the evening and morning prior to the test meal. Subjects are expected to ingest the test meal, take the provided capsules as directed and remain at the test site for a minimum of three hours following the test meal without eating, drinking or smoking.

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