Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain (NCT00020605) | Clinical Trial Compass
UnknownPhase 3
Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain
United StatesStarted 2000-05
Plain-language summary
RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid pain medications such as morphine.
PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption in patients who are receiving opioids for chronic pain.
Who can participate
Age range18 Years – 120 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS: Moderate to severe opioid-induced constipation Previously enrolled on protocols NAL-0396, NAL-0397, and/or NAL-0398 OR Low frequency of bowel movements, defined as fewer than 3 per week during the past 2 weeks, AND either of the following: Score of "some", "quite a bit", or "very much" on the constipation distress scale Laxative or enema dependence Daily opioid intake equivalent to at least 30 mg of oral morphine for chronic pain of malignant or non-malignant origin Stable dose of opioid analgesic agent for at least 2 weeks No score of "excruciating" on verbal pain scale No history of partial or complete bowel obstruction No constipation secondary to factors other than opioids (e.g., autonomic neuropathy or intra-abdominal adhesions)
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Potassium normal Other: No uncontrolled endocrinopathy or diabetes No psychiatric disorder or encephalopathy that would preclude study No clinically significant medical conditions that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Concurrent chemotherapy allowed provided patient has completed at least 1 course prior to study Endocrine therapy: Concurrent hormonal therapy allowed provided dosage is stable for at least 2…