A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of Tapentadol IR for Postoperative Pain Following Bunionectomy Surgery

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00806247
First received: December 8, 2008
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

This study was to evaluate the efficacy and safety of dosing regimens of tapentadol HCl immediate release capsules for the treatment of postoperative pain over a period of 12 hours on the first day following a bunionectomy in men and women.


Condition Intervention Phase
Pain
Postoperative Pain
Drug: tapentadol HCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of CG5503 (Tapentadol) IR for Postoperative Pain Following Bunionectomy Surgery

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Primary objective was that at least 1 of the treatment regimens with tapentadol IR was superior to placebo as measured by the sum of total pain relief and sum of pain intensity difference over 12 hours (SPRID12) on the first day after a bunionectomy.

Secondary Outcome Measures:
  • Secondary objectives included evaluation of several additional pain measures, tolerability to treatments, and drug pharmacokinetics and pharmacodynamics.

Enrollment: 480
Study Start Date: January 2005
Study Completion Date: August 2005
Detailed Description:

Tapentadol hydrochloride is a centrally active analgesic (antinociceptive) compound. This was a multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled dose study in men and nonpregnant, nonlactating women. The patients were at least 18 and no more than 75 years of age and experienced moderate to severe pain within 9 hours after removal of postoperative analgesia. The surgery was a standardized first metatarsal bunionectomy. Treatment of postsurgical pain after the 9 hr period was with either placebo, tapentadol, or oxycodone using various dosing regimens. The primary objective of this study was to evaluate the efficacy and safety of these treatments on total pain relief and total change in pain intensity over 12 hours and reporting of adverse events, laboratory values, vital signs, and ECGs. Secondary objectives included evaluation of several other pain measures, and drug pharmacokinetics and pharmacodynamics. Six patient treatment groups received study medication orally at 0, 4, and 8 hours with one of the following dosing regimens: 1) placebo, placebo, and placebo, 2) 93 mg, 93 mg, and 93 mg tapentadol IR, 3) 140 mg, 140 mg, and 140 mg tapentadol IR, 4) 140 mg, 70 mg, and 70 mg tapentadol IR, 5) 186 mg, 93 mg, and 93 mg tapentadol IR, and 6) 10 mg, 10 mg, and 10 mg oxycodone IR.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe pain intensity within 9 hours of the discontinuation of the popliteal block, and permitted supplemental systemic analgesics, if taken, during the postoperative surgical period
  • Moderate to severe categorical pain intensity and a pain intensity VAS = 40 mm

Exclusion Criteria:

  • Randomization less than 10 hours after initiation of the standardized first metatarsal bunionectomy
  • History of seizure (including febrile seizure), or loss of consciousness due to head trauma
  • Use of antiparkinsonian drugs, neuroleptics, anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), SSRIs, and SNRIs at any time within 30 days of surgery and throughout the study period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806247

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00806247     History of Changes
Other Study ID Numbers: CR004189
Study First Received: December 8, 2008
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Tapentadol
Bunionectomy
Analgesia
Acute pain
Postsurgical pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014