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CompletedNCT02487108Updated Mar 31, 2022Results posted

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

A Phase 3 interventional study of TV-46763 and Placebo in Pain, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
569
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 milligrams (mg)/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating participants with moderate to severe pain following bunionectomy.

02

Conditions studied

  • Pain
03

In context

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Men and women aged 18 to 75 years, inclusive.
  2. Participants 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. Participants who according to the American Society of Anesthesiologists Physical Status (PS) classification system are classified PS-1 (normal, healthy participant) or PS-2 (mild systemic disease).
  4. The participant 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 participant has a body mass index (BMI) between 18.0 and 33.0 kg/m2 (inclusive) at the time of screening.
  6. The participant 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 participant, 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 participants may not donate sperm for the duration of the study and for 90 days after taking study drug.
  9. The participant 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 participant must not participate in any other study involving an investigational agent while enrolled in the present study.
  11. The participant 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 participant 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

Exclusion Criteria:

  1. The participant 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 participant 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 participant has any other medical or psychiatric condition or is receiving concomitant medication/therapy that would, in the opinion of the investigator, compromise the participant's safety, compliance with the study protocol procedures, or collection of data.
  5. The participant has a clinically significant abnormality in the physical examination and/or clinical laboratory test values.
  6. The participant is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
  7. The participant has used an investigational drug within 1 month before the screening visit.
  8. The participant is participating any currently ongoing research study.
  9. The participant 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 participant safety or efficacy aspects of participation in the opinion of the investigator.
  10. The participant 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 participant has a recent history (within 5 years) or current evidence of alcohol or other substance abuse, with the exception of nicotine.
  12. The participant 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 participant has a history of suicidality as assessed by participant medical history and/or the C-SSRS.
  14. The participant is expected to have elective surgery during the study other than a bunionectomy.
  15. The participant has a history of malignancy within 5 years (except for treated basal cell carcinoma).
  16. The participant 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 participant has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first dose of study drug.
  18. The investigator believes that the participant is not suitable for the study for any reason.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
569 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Participants will receive placebo matching to TV46763 (hydrocodone bitartrate/acetaminophen) immediate release (IR) tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.

    Drug: Placebo

  • Experimental
    TV-46763 5.0 mg/325 mg

    Participants will receive TV46763 (hydrocodone bitartrate/acetaminophen) 5.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.

    Drug: TV-46763

  • Experimental
    TV-46763 7.5 mg/325 mg

    Participants will receive TV46763 (hydrocodone bitartrate/acetaminophen) 7.5 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.

    Drug: TV-46763

  • Experimental
    TV-46763 10.0 mg/325 mg

    Participants will receive TV46763 (hydrocodone bitartrate/acetaminophen) 10.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.

    Drug: TV-46763

Interventions

  • DrugTV-46763

    TV-46763 will be administered per dose and schedule specified in the arm description.

    Also known as: Hydrocodone bitartrate/acetaminophen IR tablets

  • DrugPlacebo

    Placebo matching to TV-46763 will be administered per schedule specified in the arm description.

06

What researchers measure

Primary outcomes

  1. Summed Pain Intensity Difference (SPID) Score Calculated Over the First 48 Hours (SPID48) After the First Dose of Study Drug on an 11-Point Numerical Pain Rating Scale (NPRS-11)

    The SPID48 was calculated as the time-weighted sum of pain intensity difference (PID) at each time point over 48 hours. The SPID48 was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. Least square (LS) mean was calculated using an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data.

    Time frame: 48 hours

Secondary outcomes

  1. SPID Scores Over the Intervals During the First 36 Hours Following the First Dose of Study Drug

    The SPID was calculated as the time-weighted sum of PID at each time point over the intervals during the first 36 hours. The SPID was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. LS mean was calculated using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data.

    Time frame: 0 to 6, 0 to 12, 0 to 24, and 0 to 36 hours

  2. Pain Intensity Difference (PID) Scores

    The PID was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. PID was calculated at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours after the first dose of study drug. LS mean was calculated using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data.

    Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours

  3. Time to Peak PID

    Time to peak PID after the first dose of study drug but before the second dose of study drug was calculated. Kaplan-Meier method was used to calculate the data. Multiple imputation method was used to handle missing pain intensity scores at scheduled time points.

    Time frame: Within 6 hours

  4. Number of Participants With a 30% Reduction in Pain Intensity Measured Using NPRS-11 Scores

    Number of participants with a 30% reduction in NPRS-11 scores was reported at 6, 12, 24, and 48 hours after the first dose of study drug.

    Time frame: 2, 4, 6, 12, 24, and 48 hours

  5. Number of Participants With a 50% Reduction in Pain Intensity Measured Using NPRS-11 Scores

    Number of participants with a 50% reduction in NPRS-11 scores was reported at 6, 12, 24, and 48 hours after the first dose of study drug.

    Time frame: 2, 4, 6, 12, 24, and 48 hours

  6. Time to Onset of Perceptible Pain Relief (PPR)

    Time to perceptible pain relief (PPR) (i.e., onset of pain relief) after the first dose of study drug was calculated using the stopwatch technique. The PPR stopwatch was started immediately after administration of the first dose of study drug (time zero \[T0\]) and it was given to the participant with the instructions to stop the stopwatch when he or she first perceived pain relief (time to perceptible relief). Kaplan-Meier method was used to calculate the data.

    Time frame: Day 1

  7. Time to Onset of Meaningful Pain Relief (MPR)

    Time to meaningful pain relief (MPR) after the first dose of study drug was calculated using the stopwatch technique. The MPR stopwatch was started immediately after administration of the first dose of study drug (time zero \[T0\]). The stopwatch was given to the participant with the instructions to stop the stopwatch when he or she first experienced meaningful pain relief (time to meaningful relief). Kaplan-Meier method was used to calculate the data.

    Time frame: Day 1

  8. Total Rescue Medication Use (Number of Tablets Used)

    Total rescue medication (oral nonprescription ibuprofen) use (number of tablets used) over 6, 12, 24, and 48 hours after the first dose of study drug was calculated.

    Time frame: 6, 12, 24, and 48 hours

  9. Number of Participants Taking Rescue Medication

    Number of participants taking rescue medication (oral nonprescription ibuprofen) over 6, 12, 24, and 48 hours after the first dose of study drug were calculated.

    Time frame: 6, 12, 24, and 48 hours

  10. Number of Participants With Adverse Events (AEs)

    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

    Time frame: Day 1 up to Day 13

07

Results

Posted Mar 31, 2022

Participant flow

Participant flow — Overall Study
MilestonePlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
Started142142143142
Received at least 1 dose of study drug142142141142
Completed126126117131
Not completed16162611
Withdrew: Adverse event16126
Withdrew: Withdrawal by subject8550
Withdrew: Non-compliance to study medication3254
Withdrew: Protocol violation1120
Withdrew: Non-compliance to study procedures0001
Withdrew: Other than specified3220

Outcome measures

PrimarySummed Pain Intensity Difference (SPID) Score Calculated Over the First 48 Hours (SPID48) After the First Dose of Study Drug on an 11-Point Numerical Pain Rating Scale (NPRS-11)

The SPID48 was calculated as the time-weighted sum of pain intensity difference (PID) at each time point over 48 hours. The SPID48 was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. Least square (LS) mean was calculated using an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data.

Time frame:
48 hours
Reported as:
Least squares mean · units on a scale
Summed Pain Intensity Difference (SPID) Score Calculated Over the First 48 Hours (SPID48) After the First Dose of Study Drug on an 11-Point Numerical Pain Rating Scale (NPRS-11)
units on a scalePlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
Summed Pain Intensity Difference (SPID) Score Calculated Over the First 48 Hours (SPID48) After the First Dose of Study Drug on an 11-Point Numerical Pain Rating Scale (NPRS-11)76.5 ± 6.92115.4 ± 6.92120.5 ± 6.91129.9 ± 6.88
Statistical analysis
  • Placebo vs TV-46763 5.0 mg/325 mg · ANCOVA · p = <0.001 · Ls mean difference: 38.9 · 95% CI 19.931 to 57.855
  • Placebo vs TV-46763 7.5 mg/325 mg · ANCOVA · p = <0.001 · Ls mean difference: 44.0 · 95% CI 25.122 to 62.881
  • Placebo vs TV-46763 10.0 mg/325 mg · ANCOVA · p = <0.001 · Ls mean difference: 53.4 · 95% CI 34.589 to 72.282
SecondarySPID Scores Over the Intervals During the First 36 Hours Following the First Dose of Study Drug

The SPID was calculated as the time-weighted sum of PID at each time point over the intervals during the first 36 hours. The SPID was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. LS mean was calculated using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data.

Time frame:
0 to 6, 0 to 12, 0 to 24, and 0 to 36 hours
Reported as:
Least squares mean · units on a scale
SPID Scores Over the Intervals During the First 36 Hours Following the First Dose of Study Drug
units on a scalePlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
SPID 0-63.7 ± 0.878.3 ± 0.878.3 ± 0.879.1 ± 0.88
SPID 0-126.4 ± 1.7815.8 ± 1.7716.5 ± 1.7619.1 ± 1.78
SPID 0-2421.1 ± 3.5543.9 ± 3.5344.5 ± 3.5350.9 ± 3.53
SPID 0-3644.2 ± 5.2678.2 ± 5.2681.1 ± 5.2288.2 ± 5.22
SecondaryPain Intensity Difference (PID) Scores

The PID was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. PID was calculated at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours after the first dose of study drug. LS mean was calculated using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data.

Time frame:
0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours
Reported as:
Least squares mean · units on a scale
Pain Intensity Difference (PID) Scores
units on a scalePlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
0.25 hour0.1 ± 0.110.2 ± 0.110.1 ± 0.110.0 ± 0.11
0.5 hour0.5 ± 0.150.5 ± 0.150.8 ± 0.150.5 ± 0.15
0.75 hour0.6 ± 0.170.9 ± 0.171.4 ± 0.171.1 ± 0.17
1 hour0.7 ± 0.191.4 ± 0.191.8 ± 0.191.5 ± 0.19
1.5 hours0.8 ± 0.211.6 ± 0.212.2 ± 0.212.0 ± 0.21
2 hours0.8 ± 0.201.9 ± 0.202.2 ± 0.202.1 ± 0.20
3 hours1.0 ± 0.201.8 ± 0.201.7 ± 0.201.7 ± 0.20
4 hours0.7 ± 0.191.3 ± 0.191.0 ± 0.191.3 ± 0.19
5 hours0.6 ± 0.191.4 ± 0.191.2 ± 0.191.6 ± 0.19
6 hours0.4 ± 0.191.3 ± 0.191.3 ± 0.191.7 ± 0.19
SecondaryTime to Peak PID

Time to peak PID after the first dose of study drug but before the second dose of study drug was calculated. Kaplan-Meier method was used to calculate the data. Multiple imputation method was used to handle missing pain intensity scores at scheduled time points.

Time frame:
Within 6 hours
Reported as:
Median · hours
Time to Peak PID
hoursPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
Time to Peak PID3.0 (2.02 to 3.03)2.0 (1.53 to 2.02)1.53 (1.52 to 2.01)2.0 (1.53 to 2.02)
SecondaryNumber of Participants With a 30% Reduction in Pain Intensity Measured Using NPRS-11 Scores

Number of participants with a 30% reduction in NPRS-11 scores was reported at 6, 12, 24, and 48 hours after the first dose of study drug.

Time frame:
2, 4, 6, 12, 24, and 48 hours
Reported as:
Count of participants · Participants
Number of Participants With a 30% Reduction in Pain Intensity Measured Using NPRS-11 Scores
ParticipantsPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
2 hours41717683
4 hours39444160
6 hours32565166
12 hours38555476
24 hours67838091
48 hours869692100
SecondaryNumber of Participants With a 50% Reduction in Pain Intensity Measured Using NPRS-11 Scores

Number of participants with a 50% reduction in NPRS-11 scores was reported at 6, 12, 24, and 48 hours after the first dose of study drug.

Time frame:
2, 4, 6, 12, 24, and 48 hours
Reported as:
Count of participants · Participants
Number of Participants With a 50% Reduction in Pain Intensity Measured Using NPRS-11 Scores
ParticipantsPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
2 hours27526363
4 hours20292840
6 hours18403945
12 hours22333152
24 hours46666375
48 hours73757990
SecondaryTime to Onset of Perceptible Pain Relief (PPR)

Time to perceptible pain relief (PPR) (i.e., onset of pain relief) after the first dose of study drug was calculated using the stopwatch technique. The PPR stopwatch was started immediately after administration of the first dose of study drug (time zero \[T0\]) and it was given to the participant with the instructions to stop the stopwatch when he or she first perceived pain relief (time to perceptible relief). Kaplan-Meier method was used to calculate the data.

Time frame:
Day 1
Reported as:
Median · hour
Time to Onset of Perceptible Pain Relief (PPR)
hourPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
Time to Onset of Perceptible Pain Relief (PPR)0.8 (0.50 to 1.23)0.5 (0.38 to 0.75)0.5 (0.47 to 0.68)0.6 (0.48 to 0.77)
SecondaryTime to Onset of Meaningful Pain Relief (MPR)

Time to meaningful pain relief (MPR) after the first dose of study drug was calculated using the stopwatch technique. The MPR stopwatch was started immediately after administration of the first dose of study drug (time zero \[T0\]). The stopwatch was given to the participant with the instructions to stop the stopwatch when he or she first experienced meaningful pain relief (time to meaningful relief). Kaplan-Meier method was used to calculate the data.

Time frame:
Day 1
Reported as:
Median · hour
Time to Onset of Meaningful Pain Relief (MPR)
hourPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
Time to Onset of Meaningful Pain Relief (MPR)NA (NA to NA)1.9 (1.43 to 3.02)1.3 (1.00 to 2.22)1.8 (1.25 to NA)
SecondaryTotal Rescue Medication Use (Number of Tablets Used)

Total rescue medication (oral nonprescription ibuprofen) use (number of tablets used) over 6, 12, 24, and 48 hours after the first dose of study drug was calculated.

Time frame:
6, 12, 24, and 48 hours
Reported as:
Least squares mean · tablets
Total Rescue Medication Use (Number of Tablets Used)
tabletsPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
Total rescue medication use over 6 hours1.2 ± 0.070.8 ± 0.070.7 ± 0.070.6 ± 0.07
Total rescue medication use over 12 hours2.0 ± 0.101.4 ± 0.101.4 ± 0.101.1 ± 0.10
Total rescue medication use over 24 hours3.0 ± 0.132.1 ± 0.131.9 ± 0.131.6 ± 0.13
Total rescue medication use over 48 hours4.4 ± 0.222.9 ± 0.212.6 ± 0.212.1 ± 0.22
SecondaryNumber of Participants Taking Rescue Medication

Number of participants taking rescue medication (oral nonprescription ibuprofen) over 6, 12, 24, and 48 hours after the first dose of study drug were calculated.

Time frame:
6, 12, 24, and 48 hours
Reported as:
Count of participants · Participants
Number of Participants Taking Rescue Medication
ParticipantsPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
Rescue medication use over 6 hours101767462
Rescue medication use over 12 hours124969884
Rescue medication use over 24 hours13210110793
Rescue medication use over 48 hours13210611099
SecondaryNumber of Participants With Adverse Events (AEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

Time frame:
Day 1 up to Day 13
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
Number of Participants With Adverse Events (AEs)567987106

Adverse events

Collected over Day 1 up to Day 13. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/142 (0%)2/142 (1.4%)33/142 (23.2%)
TV-46763 5.0 mg/325 mg0/142 (0%)1/142 (0.7%)66/142 (46.5%)
TV-46763 7.5 mg/325 mg0/141 (0%)0/141 (0%)80/141 (56.7%)
TV-46763 10.0 mg/325 mg0/142 (0%)0/142 (0%)98/142 (69%)
Most frequent serious events
Most frequent serious events
EventPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
Drug hypersensitivityImmune system disorders0/1421/1420/1410/142
CellulitisInfections and infestations1/1420/1420/1410/142
Deep vein thrombosisVascular disorders1/1420/1420/1410/142
Most frequent other events
Most frequent other events
EventPlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mg
NauseaGastrointestinal disorders11/14237/14254/14168/142
VomitingGastrointestinal disorders4/14218/14227/14136/142
ConstipationGastrointestinal disorders2/14226/14223/14130/142
DizzinessNervous system disorders3/14210/14224/14123/142
HeadacheNervous system disorders17/14213/14214/14124/142
PruritusSkin and subcutaneous tissue disorders2/1422/1425/14110/142
Alanine aminotransferase increasedInvestigations1/1429/1425/1415/142
SomnolenceNervous system disorders1/1428/1427/1414/142

Baseline characteristics

The intent-to-treat (ITT) analysis set included all randomized participants.

Age, Continuous
Age, Continuous(years)PlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mgTotal
Mean47.5 ± 14.3945.8 ± 14.4544.9 ± 13.8746.2 ± 13.9446.1 ± 14.16
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mgTotal
Female119124125113481
Male2318182988
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mgTotal
Hispanic or Latino40354947171
Not Hispanic or Latino1021079494397
Unknown or Not Reported00011
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboTV-46763 5.0 mg/325 mgTV-46763 7.5 mg/325 mgTV-46763 10.0 mg/325 mgTotal
White111102104107424
Black24302926109
Asian487524
American Indian or Alaskan Native11013
Native Hawaiian or Pacific Islander01012
Other20327
08

Study locations

8 sites
  • Teva Investigational Site 13510
    Phoenix, Arizona 85023, United States
  • Teva Investigational Site 13173
    Anaheim, California 92801, United States
  • Teva Investigational Site 13174
    Bakersfield, California 93311, United States
  • Teva Investigational Site 13170
    Pasadena, California 91105, United States
  • Teva Investigational Site 13169
    Pasadena, Maryland 21122, United States
  • Teva Investigational Site 13172
    San Antonio, Texas 78229, United States
  • Teva Investigational Site 13511
    Saint George, Utah 84790, United States
  • Teva Investigational Site 13171
    Salt Lake City, Utah 84124, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02487108
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
Syneos Health
Responsible party
Sponsor
First posted
Jul 1, 2015
Start date
Aug 11, 2015
Primary completion
Mar 30, 2016
Completion
Mar 30, 2016
Results posted
Mar 31, 2022
Last update
Mar 31, 2022

Study contacts

Teva Medical Expert, MD
study director · Teva Branded Pharmaceutical Products R&D, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Teva Branded Pharmaceutical Products R&D, Inc.

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