[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100148721":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":34,"centralContacts":28,"locations":28,"responsibleParty":38,"collaborators":28,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":28,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":28,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":66,"whyStopped":28,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":28},{"fullName":5,"class":6},"Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Each participant received 1 placebo capsule orally twice daily (BID) 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 0.1 mg","EXPERIMENTAL","During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.",[13,19],"Drug: ADL5945 0.1 mg",{"label":21,"type":16,"description":22,"interventionNames":23},"ADL5945 0.25 mg","During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.",[13,24],"Drug: ADL5945 0.25 mg",[26,30,32],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":28},"DRUG",null,[15,21,9],{"type":27,"name":15,"description":28,"armGroupLabels":31,"otherNames":28},[15],{"type":27,"name":21,"description":28,"armGroupLabels":33,"otherNames":28},[21],[35],{"name":36,"affiliation":5,"role":37},"Bruce Berger, MD","STUDY_DIRECTOR",{"type":39,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100148721","phase-2-evaluation-of-the-efficacy-and-safety-of-adl5945-for-the-treatment-of-opioid-induced-constipation-in-adults-taking-opioid-therapy-for-chronic-noncancer-pain-100148721",true,"NCT01207427","Evaluation of the Efficacy and Safety of ADL5945 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 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 for pain\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":52,"type":53},131,"ACTUAL","INTERVENTIONAL",[56],"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, a MOR antagonist, with placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy for chronic noncancer pain.",[59],"Opioid Induced Constipation",[61,62,63,64,65],"opioid therapy","constipation","chronic noncancer pain","mu opioid receptor antagonist","ADL5945","COMPLETED","2018-08-27",{"date":69,"type":53},"2018-09-25",{"date":71,"type":53},"2010-10-14",{"date":73,"type":53},"2011-06-28",{"name":5,"class":6}]