Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Patients With Moderate to Severe Pain Following Bunionectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02487108
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating patients with moderate to severe pain following bunionectomy

Condition or disease Intervention/treatment Phase
Pain Drug: Hydrocodone bitartrate Drug: Acetaminophen Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 569 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets (TV-46763) at Doses of 5.0 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg Every 4 to 6 Hours in Patients With Moderate to Severe Pain Following Bunionectomy
Actual Study Start Date : August 11, 2015
Actual Primary Completion Date : March 30, 2016
Actual Study Completion Date : March 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydrocodone bitartrate/acetaminophen 5.0 mg/325 mg
every 4 to 6 hours
Drug: Hydrocodone bitartrate
5.0 mg, 7.5 mg, 10 mg

Drug: Acetaminophen
325 mg

Experimental: Hydrocodone bitartrate/acetaminophen 7.5 mg/325 mg
every 4 to 6 hours
Drug: Hydrocodone bitartrate
5.0 mg, 7.5 mg, 10 mg

Drug: Acetaminophen
325 mg

Experimental: Hydrocodone bitartrate/acetaminophen 10 mg/325 mg
every 4 to 6 hours
Drug: Hydrocodone bitartrate
5.0 mg, 7.5 mg, 10 mg

Drug: Acetaminophen
325 mg

Placebo Comparator: Matching placebo
every 4 to 6 hours
Drug: Placebo
Matching Placebo




Primary Outcome Measures :
  1. Summed pain intensity difference (SPID48) Numerical pain rating [ Time Frame: 48 Hours ]
    11-point numerical pain rating scale (NPRS-11), where 0=no pain and 10=the most intense pain imaginable


Secondary Outcome Measures :
  1. Summed pain intensity difference (SPID) scores [ Time Frame: 0-6, 0-12, 0-24, and 0-36 hours ]
    Time-interval weighted SPID scores 0=no pain and 10=the most intense pain imaginable

  2. Pain intensity difference (PID) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours ]
  3. Time to peak PID [ Time Frame: Within 6 hours ]
  4. Proportion of patients with a 30% - 50% reduction in pain intensity [ Time Frame: 6, 12, 24, and 48 hours ]
  5. Time to onset of perceptible and meaningful pain relief [ Time Frame: 0.25, 0.5, 0.75, 1 hours after first dose ]
  6. Total rescue medication use [ Time Frame: 6, 12, 24, and 48 hours ]
  7. Proportion of patients taking rescue medication [ Time Frame: 6, 12, 24, and 48 hours ]
  8. Percentage of participants with adverse events [ Time Frame: 48 hours ]


Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women aged 18 to 75 years, inclusive.
  2. Patients who are scheduled to undergo a primary unilateral first metatarsal Austin bunionectomy with distal osteotomy and internal fixation without any collateral procedures (ie, uncomplicated procedure).
  3. Patients who according to the American Society of Anesthesiologists Physical Status (PS) classification system are classified PS-1 (normal, healthy patient) or PS-2 (mild systemic disease).
  4. The patient is able to speak English and is willing to provide written informed consent, including a written opioid agreement, to participate in the study.
  5. The patient has a body mass index (BMI) between 18.0 and 33.0 kg/m2 (inclusive) at the time of screening.
  6. The patient is in generally good health as determined by a medical history, medical examination, ECG, serum chemistry, hematology, urinalysis, and serology.
  7. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically acceptable method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after discontinuation of the study drug, unless they have exclusively same-sex partners. Acceptable methods of contraception include intrauterine device (IUD) known to have a failure rate of less than 1% per year, hormonal contraceptive (oral, implanted, transdermal, or injected), and barrier method with spermicide, abstinence, and partner vasectomy.

    NOTE: A woman will be considered surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy.

  8. The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using a medically acceptable method of contraception and agrees to continue use of this method for the duration of the study (and for 90 days after taking the last dose of the study drug because of the possible effects on spermatogenesis), unless he has exclusively same-sex partners. Acceptable methods of contraception include abstinence, barrier method with spermicide, female partner's use of steroidal hormonal contraceptive (oral, implanted, transdermal, or injected) in conjunction with a barrier method, female partner's use of an IUD known to have a failure rate of less than 1% per year, or if his female partner is surgically sterile or 2 years postmenopausal. In addition, male patients may not donate sperm for the duration of the study and for 90 days after taking study drug.
  9. The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
  10. The patient must not participate in any other study involving an investigational agent while enrolled in the present study.
  11. The patient must report a pain intensity score of ≥4 on an 11-point NPRS-11 within 9 hours after stopping postsurgical analgesia and immediately before randomization.
  12. The patient should be free of any surgical or anesthetic complications after the surgery, which is to be performed using the intraoperative anesthetic regimen and the postoperative analgesic regimen that was followed appropriately without deviations that would confound analgesic assessments after receipt of the investigational product.

Exclusion Criteria:

  1. The patient has a chronic pain condition, excluding bunion pain that requires taking opioid analgesics within 30 days prior to surgery or use of non-opioid analgesics (acetylsalicylic acid, acetaminophen, nonsteroidal anti-inflammatory drugs) within 24 hours prior to surgery. Stable therapy of >30 days for acetylsalicylic acid (up to 81 mg/day) is allowed as cardiovascular prophylaxis.
  2. Use of glucocorticoids (except nasal corticosteroid sprays and/or topical corticosteroids) for any condition within 6 months before study drug administration.
  3. The patient uses any nonpharmacologic pain management techniques (eg, physical techniques, physiotherapy, massage therapy, acupuncture, biofeedback, and/or psychological support) and is unable or unwilling to discontinue prior to randomization (or study start).
  4. The patient has any other medical or psychiatric condition or is receiving concomitant medication/therapy that would, in the opinion of the investigator, compromise the patient's safety, compliance with the study protocol procedures, or collection of data.
  5. The patient has a clinically significant abnormality in the physical examination and/or clinical laboratory test values.
  6. The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
  7. The patient has used an investigational drug within 1 month before the screening visit.
  8. The patient is participating any currently ongoing research study.
  9. The patient has any disorder that may interfere with gastrointestinal (GI) drug absorption (eg, gastric bypass surgery, lap band, malabsorption syndrome, and inflammatory bowel disease) or other condition that may have an effect on patient safety or efficacy aspects of participation in the opinion of the investigator.
  10. The patient is allergic to or has had a serious reaction to hydrocodone or other opioids, acetaminophen, ropivacaine, lidocaine, ketorolac, ibuprofen, propofol, or any of the drugs required by the study protocol.
  11. The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse, with the exception of nicotine.
  12. The patient has a positive urine drug screen (UDS) for cocaine, marijuana, opioids, amphetamines, methamphetamines, benzodiazepines, barbiturates, and/or methadone, unless explained by the use of prescription medication.
  13. The patient has a history of suicidality as assessed by patient medical history and/or the C-SSRS.
  14. The patient is expected to have elective surgery during the study other than a bunionectomy.
  15. The patient has a history of malignancy within 5 years (except for treated basal cell carcinoma).
  16. The patient has a positive test result for hepatitis B surface antigen or antibodies to hepatitis C, or known or tested positive for human immunodeficiency virus.
  17. The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first dose of study drug.
  18. The investigator believes that the patient is not suitable for the study for any reason.

Information from the National Library of Medicine

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): NCT02487108


Locations
Layout table for location information
United States, Arizona
Teva Investigational Site 13510
Phoenix, Arizona, United States, 85023
United States, California
Teva Investigational Site 13173
Anaheim, California, United States, 92801
Teva Investigational Site 13174
Bakersfield, California, United States, 93311
Teva Investigational Site 13170
Pasadena, California, United States, 91105
United States, Maryland
Teva Investigational Site 13169
Pasadena, Maryland, United States, 21122
United States, Texas
Teva Investigational Site 13172
San Antonio, Texas, United States, 78229
United States, Utah
Teva Investigational Site 13511
Saint George, Utah, United States, 84790
Teva Investigational Site 13171
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Syneos Health
Investigators
Layout table for investigator information
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

Layout table for additonal information
Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02487108     History of Changes
Other Study ID Numbers: TV46763-CNS-30031
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Hydrocodone
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents