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

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01813890
First received: March 15, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.


Condition Intervention Phase
Hallux Valgus
Drug: Tapentadol IR 50 mg
Drug: Tapentadol IR 75 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, 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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • SPID48 (Sum of Pain Intensity Difference) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    The SPID48 score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period allowing an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale where 0 represents "No pain" and 10 represents "Pain as bad as you can imagine". A positive difference between mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for patients dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain reduction.


Secondary Outcome Measures:
  • TOTPAR (Total Pain Relief) [ Time Frame: at 12, 24, 48, and 72 hours ] [ Designated as safety issue: No ]
    Total pain relief (PAR) is calculated on a 5-point Numeric Rating Scale. Patients indicate how much relief they had from the starting pain on a scale from 0 to 4, where 0 represents "no relief" and 4 represents "complete relief".

  • SPRID (Sum of Total Pain Relief and Sum of Pain Intensity Difference) [ Time Frame: at 12, 24, 48 and 72 hours ] [ Designated as safety issue: No ]
    The SPRID is calculated using the formula: SPRID equals SPID plus TOTPAR.

  • PGIC (Patient Global Impression of Change) [ Time Frame: at 72 hours ] [ Designated as safety issue: No ]
    The PGIC scale indicates the patient's overall status. Patients' PGIC is assessed on a 7-point Numerical Rating Scale where 1 represents "very much improved" and 7 represents "very much worse".

  • Time from first dose to the first use of rescue medication [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
    The effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication.

  • Percent change from baseline in Pain Intensity (PI) [ Time Frame: Baseline, 12, 24, 48, and 72 hours ] [ Designated as safety issue: No ]
    Pain Intensity will be calculated using an 11-point Numeric Rating Scale. Patients are asked to rate their current pain intensity on a scale from 0 to 10, where 0 represents "no pain" and 10 represents "pain as bad you can imagine".

  • SPID (Sum of Pain Intensity Difference) [ Time Frame: at 12, 24, and 72 hours ] [ Designated as safety issue: No ]
    The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period allowing an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". A positive difference between the mean SPID for an active study drug and placebo would indicate a numerically larger analgesic effect for patients dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain reduction.


Enrollment: 60
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tapentadol IR 50 mg Drug: Tapentadol IR 50 mg
Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
Experimental: Tapentadol IR 75 mg Drug: Tapentadol IR 75 mg
Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
Placebo Comparator: Placebo Drug: Placebo
Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.

Detailed Description:

Patients undergoing bunionectomy (a surgical procedure to remove a bunion, an enlargement of the joint at the base of the big toe comprised of bone and soft tissue) often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. Tapentadol (CG5503) is a newly synthesized opioid drug acting as a centrally acting analgesic like opioid analgesics but has a different mode of action. This study, a randomized (patients are assigned different treatments based on chance), double-blind (neither investigator nor patient knows which treatment the patient receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), multicenter study (the study is performed at more than one clinic) is designed to evaluate the effectiveness (level of pain control) and safety (side effects) of tapentadol immediate-release (IR) 50 mg or 75 mg versus placebo. The study will consist of a screening phase, during which the patients will be evaluated for study entry (Days -28 to -2) followed by the surgical period (Day -1) during which the bunionectomy will be performed and which will start with the first surgical incision and continues until termination of the popliteal sciatic block (PSB) infusion. During the qualification period (Day 1) which starts after termination of the post-operative continuous PSB infusion, patients will be evaluated for entry in the double blind treatment phase. Patients will be randomly assigned to one of three treatment groups to receive either 50 mg tapentadol IR, 75 mg tapentadol IR or a placebo if their PI is equal to or greater than 4 on a 0-10 numerical rating scale. The inpatient double-blind treatment period will be 72 hours in duration and will include a final end-of-double-blind evaluation (on Day 4, i.e., 72 hours after the administration of the first dose) for all patients. Any patient requiring analgesia for pain relief in addition to study drug during the double-blind treatment period will be discontinued from the study due to lack of efficacy. All patients who discontinue for lack of efficacy will complete pain assessments and the Patient Global Impression of Change (PGIC) before receiving rescue medication. Pain intensity and pain relief will be periodically assessed during the treatment period using rating scales. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. The study length, including the screening period, will be up to a maximum duration of 32 days.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be undergoing primary unilateral first metatarsal bunionectomy that includes a distal Chevron osteotomy only, with or without the Akin procedure
  • Patients must be healthy or medically stable on the basis of clinical laboratory tests performed at screening
  • Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control and have a negative serum pregnancy test at screening and a negative urine pregnancy test before surgery
  • If a male, must use an approved method of birth control and does not donate sperm from the day of study drug administration until 3 months afterwards
  • Qualifying baseline Pain Intensity must be rated as greater than or equal to 4 on an 11-point (0 to 10) PI NRS, recorded within 30 minutes before randomization, no earlier than 10 hours after the first surgical incision and within 9 hours after termination of the continuous Popliteal Sciatic Block (PSB) infusion Exclusion Criteria: - History of seizure disorder or epilepsy, severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, malignancy in the past 2 years with the exception of successfully treated basal cell carcinoma
  • Mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
  • Renal insufficiency, impaired hepatic function
  • Use of anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, serotonin norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs) or triptans
  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: NCT01813890

Locations
Taiwan
Kaohsiung, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Janssen-Cilag International NV
Grünenthal GmbH
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
  More Information

No publications provided

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01813890     History of Changes
Other Study ID Numbers: CR101093, R331333PAI3035
Study First Received: March 15, 2013
Last Updated: March 25, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Janssen-Cilag International NV:
Bunionectomy
Acute pain
Post-operative pain
Tapentadol IR
Analgesia
Hallux valgus

Additional relevant MeSH terms:
Hallux Valgus
Acute Pain
Foot Deformities
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014