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

Pain, Post-operative Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284243
• Other study ID #: REC-14-013
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2014
• Last updated: July 27, 2015
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Recro Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 in DEX-IN/placebo or to any peri- or postoperative medications used in this study.

• Have a clinically significant abnormal clinical laboratory test 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Post-operative
• Pain, Postoperative

Intervention

Drug:
• Intranasal Dexmedetomidine

• Intranasal Placebo

Locations

Country	Name	City	State
United States	Trovare Clinical Research, Inc.	Bakersfield	California
United States	Lotus Clinical Research, LLC	Pasadena	California
United States	Endeavor Clinical Trials, P.A.	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Recro Pharma, Inc.	Lotus Clinical Research, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summed pain intensity difference over the first 48 hours (SPID48).		48 hours	No
Secondary	SPID at various other time points		Up to 48 Hours	No
Secondary	Time to perceptible and meaningful pain relief		6 hours	No
Secondary	Proportion of subjects with significant pain improvement following the first study dose.		6 hours	No
Secondary	Use of rescue medication (Oral opioids)		48 hours	No
Secondary	Proportion of subjects with complete protection from PONV		24 hours	Yes