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

NCT00814580 | Completed Phase 3 Results

• 3 other identifiers: CR015040R331333PAI3022KF5503/49
• Study Type: interventional
• Target: 382
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.

Conditions

Postoperative Pain

Keywords

analgesia; postoperative pain; opioid; rotator cuff repair; labral tear repair; Bankart procedure; oxycodone; tapentadol; arthroscopic shoulder surgery

Outcome Measures

Primary Outcomes (1)

• Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)

  Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.

  3 Days (72 hours)

Secondary Outcomes (33)

• Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline

  7 Days

• Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline

  7 Days

• Summary of 30% Responder Rate (With Imputation) on Day 3

  Day 3

• Summary of 30% Responder Rate (With Imputation) on Day 7

  Day 7

• Summary of 50% Responder Rate (With Imputation) on Day 3

  Day 3

Study Arms (2)

001

EXPERIMENTAL

Tapentadol IR First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1 if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed

Drug: Tapentadol IR

002

ACTIVE COMPARATOR

Oxycodone IR First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1 if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed

Drug: Oxycodone IR

Interventions

Tapentadol IR DRUG

First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed

001

Oxycodone IR DRUG

First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1, if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed

002

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, Bankart repair
• an arthroscopic mini-open rotator cuff repair
• (an arthroscopic distal clavicle resection performed in conjunction with a rotator cuff, labral tear or Bankart repair is also permitted)
• received anesthesia administered to the shoulder by interscalene nerve block
• receive study medication as the first oral analgesic medication following the orthopedic surgical procedure and expected to have moderate to severe pain requiring oral opioids for at least 3 days after surgery.

You may not qualify if:

• Patients whose post-operative pain would require non opioid analgesia as standard of care
• received a non-allowed procedure
• received intraoperative or post-operative anesthesia and/or analgesic medications which are expected to provide post-operative analgesia for \>24 hours after discharge from the PACU (recovery room)
• received intraoperatively \>200 mg fentanyl or the morphine equivalent of another opioid (for the total procedure) or potent inhaled anesthesia (e.g., sevoflurane, isoflurane)
• received IV PCA analgesia (intravenous pump the patient controls) in the PACU or a PACU stay \>8 hours
• expected to require inpatient treatment in a hospital or rehabilitation unit post operatively
• anticipate any surgical procedure(s) within 7 days after the initial shoulder surgery
• have significant nausea and/or vomiting at the time of randomization (patients may receive an anti-emetic prior to or during surgery)
• received any of the following: long-acting or controlled-release opioids within 1-month prior to randomization
• immediate release CII opioid formulations (e.g., Opana IR, Percocet, Percodan, oxycodone IR, Dilaudid) for \>5 days total within 1 month before, and within 24 hours of, randomization
• intra-articular (within a joint) or systemic steroids (except inhalers and topical steroids), within 1 month before randomization (exception, patients on a stable dose of chronic steroids for a minimum of 3 months, for a condition other than the shoulder pain)
• use of non-steroidal anti-inflammatory drugs (NSAIDs) within 24-hours of randomization
• have taken any CIII opioid formulation (e.g., Tylenol with Codeine) \>3 days/week in the 1-month prior to randomization
• treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitors (SNRIs) within 2 weeks before randomization
• positive urine drug screen (cocaine, methadone, amphetamines, cannabinoids, opiates, benzodiazepines, barbiturates, and oxycodone)

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead
• Grünenthal GmbH: collaborator

Related Publications (1)

• Vorsanger GJ, Klopfer AM, Xiang J, Benson CJ, Moskovitz BL, Rosenthal NR. Immediate-release tapentadol or oxycodone for treatment of acute postoperative pain after elective arthroscopic shoulder surgery: a randomized, phase IIIb study. J Opioid Manag. 2013 Jul-Aug;9(4):281-90. doi: 10.5055/jom.2013.0170.

  PMID: 24353022 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Limitations and Caveats

No notable study limitations were identified by the Sponsor

Results Point of Contact

• Title: Senior Director of Clinical Development, Pain
• Organization: Ortho-McNeil Janssen Scientific Affair, LLC

GVorsang@its.jnj.com

(908)927-5469

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 25, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 20, 2012
• Results First Posted: January 10, 2012

Record last verified: 2012-11