Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone Immediate Release (IR) for Treatment of Acute Post-op Pain Following Elective Arthroscopic Shoulder Surgery

Condition(s) targeted: Postoperative Pain

Intervention: Oxycodone IR (Drug); Tapentadol IR (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ortho-McNeil Janssen Scientific Affairs, LLC

Official(s) and/or principal investigator(s):
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

The purpose of this study is to evaluate how tapentadol Immediate Release (IR) compares with oxycodone Immediate Release (IR) for treating moderate to severe post-operative pain after elective arthroscopic shoulder surgery.

Official title: A Randomized, Double-Blind, Multi-Center, Parallel-Group Study of Tapentadol Immediate Release (IR) vs. Oxycodone IR for the Treatment of Subjects With Acute Post-operative Pain Following Elective Arthroscopic Shoulder Surgery

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy measure is the sum of pain intensity difference (SPID) over 3 days.

Secondary outcome: Time to achieve adequate analgesia; response defined as 50% improvement from baseline in pain intensity; change in pain relief and pain intensity; patient and clinician impression of change; sleep questions; treatment satisfaction

Detailed description: This is a double-blind (neither the patient or the study doctor knows the name of the assigned study drug during the study), randomized (study drug selected by chance like flipping a coin), active-comparator (patient will get active drug and there is no inactive drug), outpatient study to evaluate efficacy and how well you tolerate multiple doses of tapentadol IR vs. oxycodone IR for short-term moderate to severe post-operative pain after arthroscopic shoulder surgery. About 370 patients will be equally (1: 1) assigned by chance (like flipping a coin) in a blinded (no one knows what they may be getting) fashion to receive tapentadol IR (50 mg or 100 mg) or oxycodone IR (5 mg or 10 mg) as needed for pain in a flexible dose design (patient can vary the dose received). This continues until approximately 150 patients in each treatment group, who meet certain criteria, are enrolled. The duration of treatment is set for 7 days but can go to 9 days. After obtaining informed consent, patients will have screening visit procedures to determine study eligibility. Screening (Visit 1) may begin up to 21 days prior to surgery and will continue in the post-anesthesia care unit/recovery room (PACU) (Visit 2). Routine pre-operative assessments (e. g., physical examinations, clinical laboratory assessments) will be conducted as part of routine procedures. Patients will have a urine drug test and women able to have children will have a urine pregnancy test performed as part of screening for the study. Height and weight will be taken and a sleep questionnaire will also be completed at screening. Study staff will conduct pre-operative teaching regarding post-operative pain including: the pain intensity assessment for the study (11-point numeric rating scale where 0=no pain and 10=pain as bad as you can imagine); descriptions of mild, moderate and severe pain; instructions for dosing with study medication; and completing the study diary. Eligible patients will be post-operative men and women, 18 to 80 years of age, inclusive, who have undergone elective outpatient arthroscopic shoulder surgery. Patients must have received a regional interscalene nerve block as the primary anesthetic during the procedure and do not require intravenous patient-controlled analgesia post-operatively. Patients who are expected to have moderate to severe acute post-operative pain from shoulder surgery and who are appropriate candidates for outpatient pain management with an oral opioid analgesic will be eligible. In addition, appropriate patients are expected to require oral opioid analgesia for at least 3 days post-operatively. Patients who continue to meet all study criteria post-operatively will be randomized prior to PACU discharge and will be sent home with study medication (Visit 2). All patients will be prescribed a standard regimen of cold pack application to the surgical shoulder. Patients will be instructed to take the first dose of study medication as their first oral analgesic when they have at least "moderate" pain (prior to discharge or at home). Patients will be reminded about instructions on post-operative pain that were discussed during the pre-operative screening visit. Patients will also be instructed to complete a diary assessment of their current pain intensity using the 11-point Numeric Rating Scale immediately before taking the first dose of study medication. Day 1 will be the calendar day when the patient takes the first dose of study medication. Patients whose starting pain intensity score is < 4 will be allowed to continue in the study but will be excluded from the main efficacy analysis. Starting on Day 1, patients will be instructed to complete assessments, in paper diaries, each morning and evening related to pain intensity, pain relief, and occurrences of vomiting. All patients will be contacted by telephone by a member of the study staff on the day following surgery. The staff will verify that the first dose of study medication was taken and the baseline pain intensity assessment was recorded. Patients who have not taken study medication within 24 hours of randomization will be withdrawn from the study and will be scheduled for a final study visit. All patients will receive a second telephone call from the study staff on Day 3, with an acceptable window of up to +1 day. During this telephone call, site personnel will inquire about the patient's overall status in a non-directed manner and will reinforce diary compliance. If the study staff determines it is necessary, the patient will be required to return to the study site for an unscheduled visit. Patients may take up to 2 pills (any form) of acetaminophen for pain other than post-operative shoulder pain (e. g., headache, back pain) once per day only for up to a total of 2 days during the study. Patients who take up to 325 mg/day aspirin as prevention for a heart condition will be permitted to enter the study provided they are on a stable dose for at least 1 month prior to study entry and plan to continue the same dose during the study. Visit 3 will be scheduled for Day 7 with an acceptable visit window of up to +2 days. Patients will have been dispensed enough study medication so they can continue study medication until the day of the final visit, if necessary. Patients will return to the study site on Day 7, or at the time of early discontinuation, for the final visit (Visit 3). Patients who have not discontinued from the study prior to the final visit will complete a final assessment of pain intensity and pain relief in the Case Report Form (CRF). In addition, all patients will complete a sleep questionnaire, a Patient Global Impression of Change and an assessment of satisfaction with treatment. The investigator will complete a Clinician Global Impression of Change and will record any medical resource utilization noted in the office charts (e. g., unplanned calls from the subject, unscheduled office visits, emergency room visits) in the CRF. Vital signs will be obtained and study medication will be collected and counted. Patients will have adverse events assessed and any changes in concomitant medications recorded. All patients will have post-study analgesia prescribed at the investigator's discretion. A patient may elect to take supplemental analgesic medication to treat their post-operative shoulder pain at any time during the study; however, patients who take supplemental pain medication will be considered discontinued from the study. Patients who discontinue from the double-blind phase for any reason (i. e., lack of efficacy, adverse events, patient's choice) should complete a final assessment of pain intensity, pain relief, and vomiting in the appropriate section of the diary at the time they decide to discontinue from the study and prior to taking any other medication. The patient should also contact the study staff at the time of discontinuation and be scheduled for his/her final visit. During this call the study staff will confirm with the patient that the final pain intensity and pain relief assessments were completed. Patients will be assigned by chance equally (1: 1) in a blinded (neither the patient or study doctor knows) fashion to get tapentadol IR 50 or 100 mg vs oxycodone IR 5 or 10 mg, every 4-6 hours as needed. Treatment is 7 days (but can be up to 9 days) starting on Day 1 with one capsule of study drug. A "re-dose" is permitted and may be administered as soon as one hour after the first dose. For subsequent doses, patients may take one or two capsules every 4 to 6 hours as needed.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy on the basis of medical history and vital signs and meeting the American

Society of Anesthesiology (ASA) physical status I, II, or III

- completed screening procedures and have undergone one of the following elective

outpatient arthroscopic surgical procedures: rotator cuff repair, labral tear repair, or Bankart repair

- received regional anesthesia administered by interscalene nerve block

- receive study medication as the first oral analgesic medication following the

orthopedic surgical procedure

- expected to have moderate to severe pain requiring oral opioids for at least 3 days

after surgery

Exclusion Criteria:

- Patients whose post-operative pain would require non-opioid analgesia as standard of

care

- received an inadequate block for the surgical procedure

- presence of a painful condition that could interfere with subject's assessments or

ability to differentiate post-operative shoulder pain from other painful conditions or a condition associated with more severe pain in a location other than the surgical site

- took any of the following in the month before randomization: long-acting or

controlled-release opioids, immediate-release Class II opioids (e. g.,Opana IR, Percocet, Percodan, oxycodone IR, Dilaudid), intra-articular or systemic steroids except inhalers and topical steroids, or use of NSAIDS within 24 hours of randomization including intraoperative or post-operative NSAIDS (e. g., toradol)

- treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic

antidepressants, neuroleptics, serotonin norepinephrine reuptake inhibitors within 2 weeks before randomization

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Birmingham, Alabama, United States; Recruiting

Mobile, Alabama, United States; Recruiting

Jonesboro, Arkansas, United States; Not yet recruiting

Little Rock, Arkansas, United States; Recruiting

Davis, California, United States; Recruiting

Santa Barbara, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Aurora, Colorado, United States; Recruiting

Englewood, Colorado, United States; Recruiting

Clearwater, Florida, United States; Recruiting

Deland, Florida, United States; Recruiting

Fort Myers, Florida, United States; Not yet recruiting

Royal Palm Beach, Florida, United States; Recruiting

Lauderdale Lakes, Florida, United States; Recruiting

Aventura, Florida, United States; Recruiting

Tampa, Florida, United States; Active, not recruiting

Miami, Florida, United States; Recruiting

Vero Beach, Florida, United States; Recruiting

Boise, Idaho, United States; Recruiting

Meridian, Idaho, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Lexington, Kentucky, United States; Recruiting

Brighton, Massachusetts, United States; Recruiting

Detroit, Michigan, United States; Recruiting

Camden, New Jersey, United States; Recruiting

Egg Harbor Township, New Jersey, United States; Recruiting

Syracuse, New York, United States; Recruiting

Winston Salem, North Carolina, United States; Recruiting

Tulsa, Oklahoma, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Allentown, Pennsylvania, United States; Recruiting

Altoona, Pennsylvania, United States; Recruiting

State College, Pennsylvania, United States; Recruiting

Philadelphia, Pennsylvania, United States; Recruiting

Transfer, Pennsylvania, United States; Recruiting

Columbia, South Carolina, United States; Recruiting

Nashville, Tennessee, United States; Recruiting

Austin, Texas, United States; Not yet recruiting

Austin, Texas, United States; Recruiting

Lubbock, Texas, United States; Recruiting

St George, Utah, United States; Recruiting

To learn how to participate in this trial please click here.

Starting date: December 2008
Ending date: January 2010
Last updated: September 25, 2009