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

NCT02169336 | Terminated Phase 2 Results

• 1 other identifier: REC-13-012
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Summed Pain Intensity Difference Over the First 48 Hours (SPID48).

  Pain intensity was recorded using a Numeric Rating Scale (Range 0-10) where 0 equates to no pain, and 10 equates to the worst pain imaginable. Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours. Pain intensity differences from baseline at each time point were calculated and a time weighted SPID was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.

  48 hours

Study Arms (3)

DEX-IN 35mcg

EXPERIMENTAL

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

Drug: Intranasal Dexmedetomidine

DEX-IN 50mcg

EXPERIMENTAL

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

Drug: Intranasal Dexmedetomidine

IN Placebo

PLACEBO COMPARATOR

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

Other: Intranasal Placebo

Interventions

Intranasal Dexmedetomidine DRUG

DEX-IN 35mcg; DEX-IN 50mcg

Intranasal Placebo OTHER

IN Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baudax Bio: lead
• Lotus Clinical Research, LLC: collaborator

Study Sites (3)

Trovare Clinical Research, Inc.

Bakersfield, California, United States

Location

Lotus Clinical Research, LLC

Pasadena, California, United States

Location

Endeavor Clinical Trials, P.A.

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Bunion; Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Limitations and Caveats

An interim analysis was performed that focused on the primary efficacy endpoint (SPID48). Observed effect size was determined for purposes of final sample size determination. The study was terminated following the interim analysis.

Results Point of Contact

• Title: Randall Mack
• Organization: Recro Pharma, Inc

rmack@recropharma.com

484-395-2400

Study Officials

• Neil Singla, MD

  Lotus Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 10, 2015
• Results First Posted: December 10, 2015

Record last verified: 2015-11

Locations

US (3)