A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
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ClinicalTrials.gov Identifier: NCT00613938 |
Recruitment Status :
Completed
First Posted : February 13, 2008
Results First Posted : April 23, 2010
Last Update Posted : May 9, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arthralgia Bunion Hallux Valgus Pain | Drug: Tapentadol (CG5503) Drug: oxycodone Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 901 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | February 2008 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 004
placebo 1 capsule q4-6 hrs for 3 days
|
Drug: placebo
1 capsule q4-6 hrs for 3 days |
Active Comparator: 003
oxycodone 10mg capsule q4-6 hrs for 3 days
|
Drug: oxycodone
10mg capsule q4-6 hrs for 3 days |
Experimental: 001
Tapentadol (CG5503) 50mg capsule q4-6 hrs for 3 days
|
Drug: Tapentadol (CG5503)
50mg capsule q4-6 hrs for 3 days |
Experimental: 002
Tapentadol (CG5503) 75mg capsule q4-6 hrs for 3 days
|
Drug: Tapentadol (CG5503)
75mg capsule q4-6 hrs for 3 days |
- Sum of Pain Intensity Difference Over 48 Hours (SPID48) [ Time Frame: 48 hours ]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 to First Rescue Pain Medication Use. [ Time Frame: 3 days ]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. [ Time Frame: 12 hours ]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 [ Time Frame: 24 hours ]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 [ Time Frame: Baseline and 3 days ]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 [ Time Frame: 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613938
United States, California | |
Glendale, California, United States | |
United States, Maryland | |
Pasadena, Maryland, United States | |
United States, Texas | |
Austin, Texas, United States | |
Houston, Texas, United States | |
San Antonio, Texas, United States | |
San Marcos, Texas, United States | |
United States, Utah | |
Salt Lake City, Utah, United States |
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00613938 |
Other Study ID Numbers: |
CR014116 KF5503/38 |
First Posted: | February 13, 2008 Key Record Dates |
Results First Posted: | April 23, 2010 |
Last Update Posted: | May 9, 2014 |
Last Verified: | April 2014 |
Acute pain bunionectomy tapentadol |
Hallux Valgus Arthralgia Acute Pain Pain Neurologic Manifestations Foot Deformities Musculoskeletal Diseases Joint Diseases Oxycodone Tapentadol Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents |