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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02284243
Other study ID # REC-14-013
Secondary ID
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


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
See also
  Status Clinical Trial Phase
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Completed NCT03456141 - Multimodal Analgesic Protocol to Moderate Acute Pain
Terminated NCT02169336 - Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Phase 2
Not yet recruiting NCT05950152 - Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery Phase 2
Completed NCT02675907 - Evaluation of N1539 Following Bunionectomy Surgery Phase 3
Completed NCT02678286 - Evaluation of N1539 Following Abdominoplasty Surgery Phase 3
Unknown status NCT01041313 - Memantine for Post-Operative Pain Control Phase 4
Completed NCT02540265 - Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery Phase 2
Completed NCT03154658 - Serratus Anterior Plane Block in Patients Undergoing Mastectomy Phase 4