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

NCT01813890 | Completed Phase 3 Results

• 2 other identifiers: CR101093R331333PAI3035
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hallux Valgus

Keywords

Bunionectomy; Acute pain; Post-operative pain; Tapentadol IR; Analgesia; Hallux valgus

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference (SPID) Over 48 Hours

  Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.

  48 hours

Secondary Outcomes (7)

• Time to First Rescue Medication Use

  up to 48 hours

• Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours

  12, 24, 48 and 72 hours

• Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours

  12, 24, 48 and 72 hours

• Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours

  12, 24 and 72 hours

• Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours

  12, 24, 48, and 72 hours

Study Arms (3)

Tapentadol IR 50 mg

EXPERIMENTAL

Drug: Tapentadol IR 50 mg

Tapentadol IR 75 mg

EXPERIMENTAL

Drug: Tapentadol IR 75 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tapentadol IR 50 mg DRUG

Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.

Tapentadol IR 50 mg

Tapentadol IR 75 mg DRUG

Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.

Tapentadol IR 75 mg

Placebo DRUG

Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead
• Grünenthal GmbH: collaborator

Study Sites (3)

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan District, Taiwan

Location

Related Publications (1)

• Chen YJ, Chiang CC, Huang PJ, Huang J, Karcher K, Li H. Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan. Curr Med Res Opin. 2015 Nov;31(11):2001-9. doi: 10.1185/03007995.2015.1082992. Epub 2015 Sep 21.

  PMID: 26293513 DERIVED

MeSH Terms

Conditions

Hallux Valgus; Acute Pain; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mila Etropolski, Clinical Leader
• Organization: Janssen Research & Development, L.L.C.

MEtropol@its.jnj.com

609-730-4537

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 9, 2015
• Results First Posted: January 9, 2015

Record last verified: 2014-12

Locations

TW (3)