{"id":"matching-placebo-to-fidaxomicin","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Matching placebos are inert formulations used in randomized controlled trials to maintain blinding and ensure valid comparison between active drug and control groups. This particular placebo is manufactured to be indistinguishable from fidaxomicin (a narrow-spectrum antibiotic that inhibits bacterial RNA polymerase) in terms of appearance, taste, and physical properties, allowing patients and investigators to remain unaware of treatment assignment.","oneSentence":"This is a placebo formulation designed to match the appearance and administration characteristics of fidaxomicin for blinded clinical trial comparison.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:20:18.133Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Matching placebo control for fidaxomicin clinical trials (likely Clostridioides difficile infection)"}]},"trialDetails":[{"nctId":"NCT01775397","phase":"PHASE4","title":"A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System","status":"TERMINATED","sponsor":"Astellas Pharma Europe Ltd.","startDate":"2012-11-29","conditions":"Clostridium Difficile","enrollment":12},{"nctId":"NCT00314951","phase":"PHASE3","title":"Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)","status":"COMPLETED","sponsor":"Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","startDate":"2006-05-02","conditions":"Clostridium Infections, Diarrhea","enrollment":629},{"nctId":"NCT01813448","phase":"PHASE1","title":"A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2013-02","conditions":"Pharmacokinetics of Fidaxomicin, Healthy Subjects","enrollment":36}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Matching Placebo to Fidaxomicin","genericName":"Matching Placebo to Fidaxomicin","companyName":"Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","companyId":"optimer-pharmaceuticals-llc-a-subsidiary-of-merck-co-inc-rahway-new-jersey-usa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This is a placebo formulation designed to match the appearance and administration characteristics of fidaxomicin for blinded clinical trial comparison. Used for Matching placebo control for fidaxomicin clinical trials (likely Clostridioides difficile infection).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}