Overview
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
Status:
Completed
Completed
Trial end date:
2011-07-15
2011-07-15
Target enrollment:
0
0
Participant gender:
All
All
Summary
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/or vomiting. Moreover, constipation is a common and distressing side effect of long-term opioid therapy. The 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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Cubist Pharmaceuticals LLCTreatments:
Analgesics, Opioid
Criteria
Key Inclusion Criteria- be a man or woman aged 18 to 75 years, inclusive, at the time of screening
- have a body weight ≥45 kilograms (kg) and a body mass index (BMI) ≤40 kilograms per
square meter (kg/m^2)
- 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
- have opioid-induced constipation (OIC) by history. Additionally, based on the data
collected during the 1-week screening period, participants must have <3 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
- be willing to discontinue use of all laxatives and stool softeners during the study
period except as allowed by the protocol
Key Exclusion Criteria
- be pregnant, lactating, or planning to become pregnant during the study
- have aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea
nitrogen, or serum creatinine results ≥2 times the upper limit of normal
- have a recent history of myocardial infarction (MI) or unstable angina
- have an active malignancy of any type
- be taking opioids primarily for fibromyalgia
- be taking methadone as a maintenance medication (participants taking methadone for
pain may be enrolled)
- be taking intrathecal opioids for the management of pain
- be taking tramadol, tapentadol, or any mixed agonist/antagonist opioid analgesics as
the sole opioid for analgesia
- be taking any μ-opioid receptors (MOR) antagonist, including opioids in combination
with naloxone, naltrexone, or methylnaltrexone bromide
- be taking medical marijuana
- have gastrointestinal (GI) or pelvic disorders known to affect bowel transit, produce
GI obstruction, or contribute to bowel dysfunction
- have taken antispasmodics, antidiarrheals, or prokinetics within 7 days before the
start of the screening week
- be taking nonopioid medications known to cause constipation
- be taking antidiarrheals and have an incidence or a history of intermittent diarrhea
or loose stools
- be unwilling to abstain from grapefruit and grapefruit-containing products
- have a history of alcoholism or illicit drug dependence or abuse within 5 years before
screening
- have positive results on a urine drug screen (excluding opioids) that indicate illicit
drug use