Intravenous Tapentadol in Post-Bunionectomy Pain

NCT01435577 | Completed Phase 2 Results

• 1 other identifier: 295054
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.

Conditions

Bunion; Pain

Keywords

Bunionectomy; Postsurgical Pain; Acute Pain

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Differences (SPID 24)

  Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain intensity and positive values indicate an increase in pain intensity since baseline.

  Baseline value; up to 24 hours after first study drug administration

Secondary Outcomes (23)

• Mean Pain Intensity Scores at Fixed Time Points

  Baseline; up to 48 hours

• Pain Intensity Differences at Fixed Time Points

  Starting at 15 minutes and up to 48 hours after first drug administration

• Patient Global Impression of Change After 12 Hours of Treatment

  Baseline value to 12 hours after first study drug administration

• Patients Global Impression of Change After 24 Hours of Treatment

  Baseline value to 24 hours after study drug administration

• Patient Global Impression of Change After 48 Hours of Treatment

  Baseline value to 48 hours after first study drug administration

Study Arms (2)

Tapentadol intravenous

EXPERIMENTAL

Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.

Drug: Tapentadol

Matching placebo intravenous

PLACEBO COMPARATOR

Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.

Drug: Matching Placebo

Interventions

Tapentadol DRUG

30 mg per administration, maximum 12 administrations over 48 hours

Also known as: Palexia, Nucynta

Tapentadol intravenous

Matching Placebo DRUG

Maximum 12 administrations over 48 hours

Matching placebo intravenous

Eligibility Criteria

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

You may qualify if:

• Scheduled to undergo primary unilateral first metatarsal bunionectomy
• Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
• Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).

You may not qualify if:

• History of malignancy within the past 2 years
• Current or history of alcohol or drug abuse.
• Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
• History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
• Severely impaired renal function
• Moderately or severely impaired hepatic function
• Contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients
• Use of prohibited concomitant medication, or not allowed use of restricted concomitant medication

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Bunion; Pain; Pain, Postoperative; Acute Pain

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Grünenthal GmbH

+241 569 3223

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 16, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: October 28, 2019
• Results First Posted: June 24, 2013

Record last verified: 2019-10

Locations

US (1)