Constipation Drug Induced Clinical Trial
Official title:
Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department
Verified date | April 2023 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Complaint of opioid-induced constipation refractory to other therapy (enemas, laxatives, stool softeners) - Age=18y/o - Not pregnant or lactating (negative urinary pregnancy test) - No contraindication to Methylnaltrexone or Naloxegol Exclusion Criteria: - Age<18y/o - Pregnancy or lactation - Contraindication to Methylnaltrexone or Naloxegol - Assigned NPO - Small bowel obstruction |
Country | Name | City | State |
---|---|---|---|
United States | Kara B. Goddard | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Anantharamu T, Sharma S, Gupta AK, Dahiya N, Singh Brashier DB, Sharma AK. Naloxegol: First oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):188-92. doi: 10.4103/0976-500X — View Citation
Bowers BL, Crannage AJ. The Evolving Role of Long-Term Pharmacotherapy for Opioid-Induced Constipation in Patients Being Treated for Noncancer Pain. J Pharm Pract. 2019 Oct;32(5):558-567. doi: 10.1177/0897190017745395. Epub 2017 Dec 5. — View Citation
Jones R, Prommer E, Backstedt D. Naloxegol: A Novel Therapy in the Management of Opioid-Induced Constipation. Am J Hosp Palliat Care. 2016 Nov;33(9):875-880. doi: 10.1177/1049909115593937. Epub 2015 Jul 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Bowel Movement | The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation. | 24 hours | |
Secondary | Subcutaneous vs Oral | The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy. | 24 hours |
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