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A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

Primary Purpose

Arthralgia, Bunion, Hallux Valgus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tapentadol (CG5503)
Tapentadol (CG5503)
oxycodone
placebo
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthralgia focused on measuring Acute pain, bunionectomy, tapentadol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must undergo primary unilateral first metatarsal bunionectomy
  • Pain intensity must be moderate to severe following removal of a continuous popliteal sciatic block
  • Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active.

Exclusion Criteria:

  • Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
  • History of malignancy within the past 2 years before starting the study
  • History of alcohol or drug abuse
  • Evidence of active infections that may spread to other areas of the body
  • Clinical laboratory values reflecting severe renal insufficiency
  • Moderately or severely impaired hepatic function
  • Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Arm Label

004

003

001

002

Arm Description

placebo 1 capsule q4-6 hrs for 3 days

oxycodone 10mg capsule q4-6 hrs for 3 days

Tapentadol (CG5503) 50mg capsule q4-6 hrs for 3 days

Tapentadol (CG5503) 75mg capsule q4-6 hrs for 3 days

Outcomes

Primary Outcome Measures

Sum of Pain Intensity Difference Over 48 Hours (SPID48)
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.

Secondary Outcome Measures

Time to First Rescue Pain Medication Use.
The effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication.
The SPID at 12 Hours Relative to First Dose.
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID12 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.
SPID at 24 Hours Relative to First Dose
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID24 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.
Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3
Ordinal measure indicating change from the start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) to endpoint at Day 3
Total Pain Relief (TOTPAR)at 48 Hours
Total Pain Relief (TOTPAR48) was defined as the weighted sum over all pain relief scores(PAR) from 0.5 hour to Hour 48, with the actual time elapsed from the previous PAR observation as the weight. A higher value in TOTPAR indicates greater pain relief.

Full Information

First Posted
January 31, 2008
Last Updated
April 24, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
GrĂ¼nenthal GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00613938
Brief Title
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
Official Title
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
GrĂ¼nenthal GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.
Detailed Description
Patients undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, and less frequently, respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting analgesic but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 2 dose levels of tapentadol (CG5503) IR compared to no drug (placebo) or one dose level of oxycodone (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment is received), active- and placebo-controlled, parallel-group, multicenter study to evaluate treatment of the acute pain from bunionectomy. The study will include a blinded 72 hour inpatient (the patient will stay in the facility where the procedure is done) phase immediately following bunionectomy, during which patients will be treated with either 50- or 75-mg tapentadol (CG5503) IR, a placebo, or 10-mg oxycodone IR, and pain relief will be periodically assessed. Assessments of pain intensity (PI) and pain relief (PAR) are obtained using the numerical rating scale, and the patient global impression of change scale (PGIC) will measure overall patient status. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of tapentadol (CG5503) and oxycodone. The study hypotheses are that at least one tapentadol (CG5503) IR dose will be different from placebo in controlling patients pain at 48 hours, followed by establishing that at least one tapentadol (CG5503) IR dose will be non-inferior compared with oxycodone IR (oxycodone IR is not clinically significantly better than a tapentadol (CG5503) IR dose). A comparison of the incidence rate of the adverse events of nausea and/or vomiting, and the incidence rate of the adverse event of constipation, between tapentadol (CG5503) IR and oxycodone IR will also be performed. Tapentadol (CG5503) IR 50 or 75 mg, or oxycodone 10 mg, or placebo, 1 capsule taken by mouth every 4 to 6 hours during the 72-hour postsurgery phase of the study (acetaminophen is also allowed during the first 12 hours on Day 1, if needed for pain). All doses of study treatment will be taken with approximately 120 mL of water with or without food.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthralgia, Bunion, Hallux Valgus, Pain
Keywords
Acute pain, bunionectomy, tapentadol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
901 (Actual)

8. Arms, Groups, and Interventions

Arm Title
004
Arm Type
Placebo Comparator
Arm Description
placebo 1 capsule q4-6 hrs for 3 days
Arm Title
003
Arm Type
Active Comparator
Arm Description
oxycodone 10mg capsule q4-6 hrs for 3 days
Arm Title
001
Arm Type
Experimental
Arm Description
Tapentadol (CG5503) 50mg capsule q4-6 hrs for 3 days
Arm Title
002
Arm Type
Experimental
Arm Description
Tapentadol (CG5503) 75mg capsule q4-6 hrs for 3 days
Intervention Type
Drug
Intervention Name(s)
Tapentadol (CG5503)
Intervention Description
50mg capsule q4-6 hrs for 3 days
Intervention Type
Drug
Intervention Name(s)
Tapentadol (CG5503)
Intervention Description
75mg capsule q4-6 hrs for 3 days
Intervention Type
Drug
Intervention Name(s)
oxycodone
Intervention Description
10mg capsule q4-6 hrs for 3 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 capsule q4-6 hrs for 3 days
Primary Outcome Measure Information:
Title
Sum of Pain Intensity Difference Over 48 Hours (SPID48)
Description
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Time to First Rescue Pain Medication Use.
Description
The effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication.
Time Frame
3 days
Title
The SPID at 12 Hours Relative to First Dose.
Description
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID12 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.
Time Frame
12 hours
Title
SPID at 24 Hours Relative to First Dose
Description
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID24 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.
Time Frame
24 hours
Title
Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3
Description
Ordinal measure indicating change from the start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) to endpoint at Day 3
Time Frame
Baseline and 3 days
Title
Total Pain Relief (TOTPAR)at 48 Hours
Description
Total Pain Relief (TOTPAR48) was defined as the weighted sum over all pain relief scores(PAR) from 0.5 hour to Hour 48, with the actual time elapsed from the previous PAR observation as the weight. A higher value in TOTPAR indicates greater pain relief.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must undergo primary unilateral first metatarsal bunionectomy Pain intensity must be moderate to severe following removal of a continuous popliteal sciatic block Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active. Exclusion Criteria: Patients will be excluded from the study if they have a history of seizure disorder or epilepsy History of malignancy within the past 2 years before starting the study History of alcohol or drug abuse Evidence of active infections that may spread to other areas of the body Clinical laboratory values reflecting severe renal insufficiency Moderately or severely impaired hepatic function Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Glendale
State/Province
California
Country
United States
City
Pasadena
State/Province
Maryland
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
San Marcos
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19445652
Citation
Daniels S, Casson E, Stegmann JU, Oh C, Okamoto A, Rauschkolb C, Upmalis D. A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain. Curr Med Res Opin. 2009 Jun;25(6):1551-61. doi: 10.1185/03007990902952825. Erratum In: Curr Med Res Opin. 2009 Jun;25(6):1561. Dosage error in article text.
Results Reference
derived

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A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

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