Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy

NCT ID: NCT02169336

Last Updated: 2015-12-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-10-31

Brief Summary

The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.

Conditions

Pain, Post-operative

Keywords

Bunion; Bunionectomy; Pain; Analgesia; dexmedetomidine; intranasal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DEX-IN 35mcg

DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.

Group Type: EXPERIMENTAL

Intranasal Dexmedetomidine

Intervention Type: DRUG

DEX-IN 50mcg

DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.

Group Type: EXPERIMENTAL

Intranasal Dexmedetomidine

Intervention Type: DRUG

IN Placebo

IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.

Group Type: PLACEBO_COMPARATOR

Intranasal Placebo

Intervention Type: OTHER

Interventions

Intranasal Dexmedetomidine

Intervention Type: DRUG

Intranasal Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Voluntarily provide written informed consent.
• Male or female between 18 and 70 years of age, inclusive.
• Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair
• Be American Society of Anesthesiology (ASA) physical class 1 or 2.
• Female subject are eligible only if all the following apply:

• Not pregnant;
• Not lactating;
• Not planning to become pregnant during the study;
• Be surgically sterile; or at least two year post menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive.
• Male subjects must be surgically sterile or commit to the use of a reliable method of birth control
• Have a body mass index ≤35 kg/m2
• Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.

Exclusion Criteria

• Have a known allergy to dexmedetomidine or any excipient DEX-IN/placebo or to any peri- or postoperative medications used in this study.
• Have a clinically significant abnormal clinical laboratory tests value.
• Have history of or positive test results for HIV, or hepatitis B or C.
• Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
• Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
• Have another painful physical condition that may confound the assessments of post operative pain.
• Have a history of syncope or other syncopal attacks.
• Have evidence of a clinically significant 12 lead ECG abnormality.
• Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse..
• Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
• Have a history or evidence of orthostatic hypotension.
• Have a resting heart rate of <50 beats per minutes or systolic blood pressure <100mmHg.
• Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months.
• Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigator's opinion may exert significant analgesic properties or act synergistically with DEX-IN.
• Unable to discontinue medications, that have not been at a stable dose for at least 14 days prior to the scheduled bunionectomy procedure, within 5 half lives of the specific prior medication (or, if half life is not known, within 48 hours) before dosing.
• Have utilized any intranasal medications within the preceding 10 days.
• Have signs or a history of significant rhinitis or rhinorrhea (constant or chronic), nasal polyps, mucosal lesions of the nostril, postnasal drip of any etiology (constant or chronic), nasal ulcers, septal perforation or deviation, any nasal surgery, anosmia, nasal piercings, or frequent nosebleeds or other nasal pathology, that is sufficient to interfere with IN drug delivery.
• Have had an upper respiratory tract infection within 14 days of screening.
• Have utilized corticosteroids, either systemically, inhalational either intranasally or oral, or by intra-articular injection, within 14 days prior to the study.
• Have received any investigational product within 30 days before dosing with study medication.
• Have previously received DEX-IN in clinical trials, or had bunionectomy in the last 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lotus Clinical Research, LLC

OTHER

Sponsor Role: collaborator

Baudax Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Singla, MD

Role: PRINCIPAL_INVESTIGATOR

Lotus Clinical Research, LLC

Locations

Trovare Clinical Research, Inc.

Bakersfield, California, United States

Lotus Clinical Research, LLC

Pasadena, California, United States

Endeavor Clinical Trials, P.A.

San Antonio, Texas, United States

Countries

United States

Other Identifiers

REC-13-012

Identifier Type: -

Identifier Source: org_study_id