A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement (ARX-F01)

January 22, 2014 updated by: AcelRx Pharmaceuticals, Inc.
The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01-treated subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Trio Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients between 45 to 80 years of age.
  • Patient is scheduled for an elective, unilateral, unicondylar, bi- or tri-compartmental, cemented or uncemented knee replacement under general or spinal anesthesia that does not include use of an intrathecal opioid.
  • Patient must be classified as American Society of Anesthesiologists (ASA) class I - III.
  • Patient must have Body Mass Index [BMI = weight (kg)/height (m2)] between 18 and 39, inclusively.
  • Female patients of childbearing potential must be using an effective method of birth control from the screening visit through the end of study. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for ≥1 year, must be specified in the patient's case report form (CRF).
  • The patient must be willing and able to understand the study procedures and the use of pain scales, and to communicate meaningfully with the study personnel.
  • The patient must provide written informed consent and sign the Informed Consent approved by the Institutional Review Board (IRB).

Exclusion Criteria:

  • Patient has previously undergone a knee replacement of the same knee.
  • A passive range-of-motion (PRM) will be used before the 12-hour study period is complete
  • Patient has previously not responded to opioid analgesics for treatment of pain.
  • Patient is currently taking or has taken an opioid for more than 30 consecutive days of daily use at a daily dose equivalent to greater than 15 mg morphine within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
  • Patient has an allergy or hypersensitivity to opioids.
  • Patient currently has sleep apnea that has been documented by a sleep laboratory study.
  • Patient has any screening laboratory test value outside the laboratory normal range which is considered clinically significant by the Investigator.
  • Patient has a contraindication to the use of general anesthesia.
  • Patient is a woman who is pregnant or lactating.
  • Patient has psychiatric disease or encephalopathy severe enough to prevent patient from providing reliable study documentation.
  • Patient, in the Investigator's judgment, does not have adequate ability to read and understand English.
  • Patient has a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including fracture or active infection.
  • Patient has clinically significant renal or liver impairment which could affect metabolism or clearance of sufentanil.
  • Patient has a painful physical condition other than knee arthritis that, in the opinion of the Investigator, may confound post-operative pain assessments.
  • Patient has a history of drug, prescription medicine, or alcohol abuse within the past 2 years or a positive test for drugs of abuse at screening.
  • Patient is receiving oxygen therapy at the time of screening.
  • Patient participated in a clinical trial of an investigational drug or device within 30 days of screening visit or is scheduled to receive an investigational product other than ARX-F01 while participating in this study.

Exclusion Criteria at Randomization (during early PACU time period):

  • Patient has a respiratory rate that is less than 8 breaths per minute or greater than 24 breaths per minute,
  • Patient has arterial oxygen saturation by pulse oximetry (SpO2) of less than 90% with supplemental oxygen.
  • Patient is not able to answer questions and follow commands.
  • Patient has vomiting that is not responsive to standard treatment.
  • The surgical procedure from incision to closure was longer than 3 hours.
  • There have been any deviations from the surgical or anesthetic protocols as specified in the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Sufentanil NanoTab
5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other Names:
  • ARX-F01
Drug: Sufentanil NanoTab
10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other Names:
  • ARX-F01
Drug: Sufentanil NanoTab
15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other Names:
  • ARX-F01
Experimental: 2
Drug: Sufentanil NanoTab
5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other Names:
  • ARX-F01
Drug: Sufentanil NanoTab
10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other Names:
  • ARX-F01
Drug: Sufentanil NanoTab
15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other Names:
  • ARX-F01
Experimental: 3
Drug: Sufentanil NanoTab
5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other Names:
  • ARX-F01
Drug: Sufentanil NanoTab
10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other Names:
  • ARX-F01
Drug: Sufentanil NanoTab
15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other Names:
  • ARX-F01
Placebo Comparator: 4
Drug: Placebo NanoTab
Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPID-12
Time Frame: 12 hours after first dose
SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protocol, pain scores are collected at 15 different time points. If all scores are collected, the full range of SPID-12 scores could be -150 to 150.
12 hours after first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AcelRx Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

February 17, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARX-C-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Operative Pain

Clinical Trials on Sufentanil NanoTab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe