An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement

NCT00859313 | Completed Phase 2 Results

• 1 other identifier: ARX-C-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery. Another goal of this study is to assess the safety and effectiveness of this non-invasive, sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient experiences following knee replacement surgery.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Percent of Patients Without Device Failure

  Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.

  12 hours

Study Arms (1)

Sufentanil NanoTab PCA System/15 mcg

EXPERIMENTAL

Drug: Sufentanil NanoTab PCA System/15 mcg

Interventions

Sufentanil NanoTab PCA System/15 mcg DRUG

15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

Sufentanil NanoTab PCA System/15 mcg

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between 45 and 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 a Body Mass Index (BMI) 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 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 have the manual dexterity to handle the Sufentnail NanoTab PCA System and be able to follow directions for its use.
• The patient must provide written informed consent and sign the Informed Consent approved by the Institutional Review Board (IRB).

You may not qualify if:

• 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 of greater than 15 mg morphine within the past three 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 is taking monoamine oxidase inhibitors (MAOIs), or has taken MAOIs within 14 days prior to enrolling in the study.
• 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 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 drug screen test for cocaine, amphetamines, barbiturates, phencyclidine, or methadone at screening.

Sponsors & Collaborators

• Talphera, Inc: lead

Study Sites (3)

West Alabama Research, Inc

Birmingham, Alabama, 35209, United States

Location

Orthopedic Center of Vero Beach

Vero Beach, Florida, 32960, United States

Location

Memorial Hermann/Memorial City Medical Center

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Pamela Palmer
• Organization: AcelRx Pharmaceuticals, Inc.

ppalmer@acelrx.com

650-216-3504

Study Officials

• Pamela P Palmer, MD PhD

  Talphera, Inc

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 1, 2012
• Results First Posted: February 27, 2012

Record last verified: 2012-02

Locations

US (3)