[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100153941":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":27,"collaborators":23,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":23,"eligibilityCriteria":35,"healthyVolunteers":36,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":23,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":56,"whyStopped":23,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":23},{"fullName":5,"class":6},"Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"ADL5945 0.25 mg","EXPERIMENTAL","During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.",[13,19],"Drug: ADL5945 0.25 mg",[21,25],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":23},"DRUG",null,[15,9],{"type":22,"name":15,"description":23,"armGroupLabels":26,"otherNames":23},[15],{"type":28,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100153941","phase-2-evaluation-of-the-efficacy-and-safety-of-adl5945-once-daily-for-the-treatment-of-opioid-induced-constipation-in-adults-taking-opioid-therapy-for-chronic-noncancer-pain-100153941",true,"NCT01275755","Evaluation of the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain","A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain","Key Inclusion Criteria\n\n* be a man or woman aged 18 to 75 years, inclusive, at the time of screening\n* have a body weight ≥45 kilograms (kg) and a body mass index (BMI) ≤40 kilograms per square meter (kg\u002Fm\\^2)\n* be taking a stable daily dose of opioids of ≥30-milligrams (mg) morphine-equivalent total -daily dose for chronic noncancer pain for ≥30 days before screening\n* have opioid-induced constipation (OIC) by history. Additionally, based on the data collected during the 1-week screening period, participants must have \\\u003C3 spontaneous bowel movements (SBMs) per week and have experienced ≥1 other bowel movement (BM) symptom (that is, straining to pass a stool, lumpy hard stools or small pellets, or sense of incomplete evacuation after passing a stool) for ≥25% of the total BMs\n* be willing to discontinue use of all laxatives and stool softeners during the study period except as allowed by the protocol\n\nKey Exclusion Criteria\n\n* be pregnant, lactating, or planning to become pregnant during the study\n* have aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen, or serum creatinine results ≥2 times the upper limit of normal\n* have a recent history of myocardial infarction (MI) or unstable angina\n* have an active malignancy of any type\n* be taking opioids primarily for fibromyalgia\n* be taking methadone as a maintenance medication (participants taking methadone for pain may be enrolled)\n* be taking intrathecal opioids for the management of pain\n* be taking tramadol, tapentadol, or any mixed agonist\u002Fantagonist opioid analgesics as the sole opioid for analgesia\n* be taking any μ-opioid receptors (MOR) antagonist, including opioids in combination with naloxone, naltrexone, or methylnaltrexone bromide\n* be taking medical marijuana\n* have gastrointestinal (GI) or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction\n* have taken antispasmodics, antidiarrheals, or prokinetics within 7 days before the start of the screening week\n* be taking nonopioid medications known to cause constipation\n* be taking antidiarrheals and have an incidence or a history of intermittent diarrhea or loose stools\n* be unwilling to abstain from grapefruit and grapefruit-containing products\n* have a history of alcoholism or illicit drug dependence or abuse within 5 years before screening\n* have positive results on a urine drug screen (excluding opioids) that indicate illicit drug use",false,"ALL","18 Years","75 Years",{"count":41,"type":42},81,"ACTUAL","INTERVENTIONAL",[45],"PHASE2","Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI tract. The most common symptoms associated with the effects of opioids are constipation and nausea and\u002For vomiting. Moreover, constipation is a common and distressing side effect of long-term opioid therapy.\n\nThe primary objective of this study was to compare ADL5945 once daily, a MOR antagonist, with placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy for chronic noncancer pain.",[48],"Constipation",[50,51,52,53,54,55],"opioid therapy","constipation","chronic noncancer pain","mu opioid receptor antagonist","ADL5945","Opioid Induced Constipation","COMPLETED","2018-10-17",{"date":59,"type":42},"2018-11-15",{"date":61,"type":42},"2011-01-19",{"date":63,"type":42},"2011-07-15",{"name":5,"class":6}]