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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.
Opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. Not only are the medical complications potentially severe, patient quality of life can also be impacted. Two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. Mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. The literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylnaltrexone oral tablets | Active Comparator | Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. |
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| Methylnaltrexone subcutaneous injection | Active Comparator | Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. |
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| Naloxegol oral tablets | Active Comparator | Naloxegol oral tablets (total 25 mg) + subcutaneous water injection Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone Bromide 150 mg Oral Tablet | Drug | Methylnaltrexone Bromide 150 mg Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Bowl 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Bowl Movement Within 24 Hours | The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy. | 24 hours after administration of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KARA B GODDARD, PharmD, BCPS | UNIVERSITY OF MISSOURI HEALTH CARE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kara B. Goddard | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29207909 | Background | 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. | |
| 26150678 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylnaltrexone Oral Tablets | Methylnaltrexone oral tablets (total 450 mg) Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Methylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2023 | Aug 9, 2024 |
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Participants will be assigned to one of three groups i. Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection ii. Methylnaltrexone 12mg subcutaneous injection + placebo sugar tablets iii. Naloxegol oral tablets (total 25 mg) + subcutaneous water injection
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Each participant will be receiving one injection and tablets which have been randomly assigned.
| Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 | Drug | Methylnaltrexone Bromide 12 MG Subcutaneous Solution |
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| Naloxegol 25 MG Oral Tablet | Drug | Naloxegol 25 MG Oral Tablet |
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| 26312011 | Result | 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.162015. |
| FG001 | Methylnaltrexone Subcutaneous Injection | Methylnaltrexone 12mg subcutaneous injection Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution |
| FG002 | Naloxegol Oral Tablets | Naloxegol oral tablets (total 25 mg) Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylnaltrexone Oral Tablets | Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Methylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet |
| BG001 | Methylnaltrexone Subcutaneous Injection | Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution |
| BG002 | Naloxegol Oral Tablets | Naloxegol oral tablets (total 25 mg) + subcutaneous water injection Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Bowl 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. | The number of participants who had a successful bowl movement within 24 hours of administration of study drug | Posted | Count of Participants | Participants | 24 hours |
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| Secondary | Time to Bowl Movement Within 24 Hours | The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy. | Posted | Mean | Standard Deviation | minutes | 24 hours after administration of study drug |
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24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methylnaltrexone Oral Tablets | Methylnaltrexone oral tablets (total 450 mg) Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Methylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet | 0 | 4 | 0 | 4 | 1 | 4 |
| EG001 | Methylnaltrexone Subcutaneous Injection | Methylnaltrexone 12mg subcutaneous injection Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Naloxegol Oral Tablets | Naloxegol oral tablets (total 25 mg) Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours. Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet | 0 | 5 | 0 | 5 | 2 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Social circumstances | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kara B. Goddard | University of Missouri Health Care | 5738841605 | goddardk@health.missouri.edu |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2024 | Sep 4, 2024 | SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2020 | Apr 6, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
| D013607 | Tablets |
| C000589308 | naloxegol |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Naloxegol oral tablets (total 25 mg)
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet
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