Phase 2 Herniorrhaphy Study for Opioid Elimination
Sponsor:
Heron Therapeutics
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | October 1, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | October 1, 2018 | ||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Proportion of subjects receiving no opioid rescue[ Time Frame: 72 hours ] |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Phase 2 Herniorrhaphy Study for Opioid Elimination |
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| Official Title ICMJE | A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy |
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| Brief Summary | This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy. |
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| Detailed Description | |||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 2 | ||
| Study Design ICMJE | Allocation: Intervention Model: Single Group Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Prevention |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
30 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | January 2019 | ||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia. - Has an American Society of Anesthesiologists Physical Status of I, II, or III. - Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives. Exclusion Criteria: - Had any prior inguinal hernia repair except as a child (less than 6 years of age). - Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy). - Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. - Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. - Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. - Has taken any NSAIDs within least 10 days prior to the scheduled surgery. - Has taken long-acting opioids within 3 days prior to the scheduled surgery. - Has taken any opioids within 24 hours prior to the scheduled surgery. - Has been administered bupivacaine within 5 days prior to the scheduled surgery. - Has been administered any local anesthetic within 72 hours prior to the scheduled surgery. - Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control. - Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. - Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. - As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV). - Has uncontrolled anxiety, psychiatric, or neurological disorder. - Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. - Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study. - Previously participated in an HTX-011 study. - Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives. - Has undergone 3 or more surgeries within 12 months. - Has a body mass index (BMI) >39 kg/m2. | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | ||
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: Yes |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Heron Therapeutics | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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