Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
|ClinicalTrials.gov Identifier: NCT01400139|
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : December 4, 2014
Last Update Posted : October 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Nonmalignant and Nonneuropathic Pain||Drug: Hydrocodone bitartrate q24h film-coated tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||922 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter Study to Assess the Long -Term Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Hydrocodone bitartrate
Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Drug: Hydrocodone bitartrate q24h film-coated tablets
Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
Other Name: Hysingla ER
- The Number of Participants With Adverse Events as a Measure of Safety [ Time Frame: Up to 84 weeks ]Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.
- Daily "Average Pain Over the Last 24 Hours" [ Time Frame: Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks) ]"Average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).
- "Pain Right Now" Score [ Time Frame: Week 12 ]"Pain right now" scores were collected using an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. The "pain right now" scores were only collected during the Core Study. "Pain right now" scores were not assessed during the Extension Period.
- Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) [ Time Frame: Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period ]The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep: sleep problems index II and 6 subscale scores - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. For the derived scores in the MOS Sleep-R, a higher score indicates a better sleep pattern.
- Brief Pain Inventory Short Form (BPI-SF) - Pain Interference [ Time Frame: Up to 52 weeks in maintenance and up to 24 weeks in extension ]The BPI-SF questionnaire was used to assess the severity of pain and the interference of pain on daily functions. It consists of 9 sections that measure pain location, intensity, pain treatment, and functional interference of pain on mood and every day activities. Four of the items (questions 3 through 6) assess the severity of pain and 7 items (questions 9A through 9G) assess the interference of pain. The pain severity subscale was determined by calculating the arithmetic mean of the responses to items 3, 4, 5 and 6. For BPI, a lower score indicates a lower pain.
- Medical Outcomes Study 36-item Short Form (SF-36) [ Time Frame: Up to 52 weeks in maintenance and up to 24 weeks in extension ]The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The 36 questions are grouped into 11 sections. Some of the sections consist of multiple questions. The survey is summarized into 8 dimensions/scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. From the 8 health dimensions, physical component summary, and mental component summary measures are derived. For SF-36, a higher score indicates a better perception of health.
- Patient Global Impression of Change (PGIC) [ Time Frame: At Week 52 in maintenance and at Week 24 in extension ]The PGIC is an ordinal scale of global evaluation that assesses the change in overall status relative to the start of the study. The scale has only 1 item that measures global change of overall status (improvement or worsening) by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. The proportion of subjects with a response of "much improved" (category 2) and "very much improved" (category 1), is provided along with 95% confidence intervals for the proportion.
- Treatment Satisfaction Questionnaire (TSQ) - Part I [ Time Frame: At Week 52 or upon early discontinuation at or before Week 4 in maintenance ]The TSQ is a self-administered questionnaire that consists of 2 parts. Part I has 6 questions (Q1 to Q6) that ask the subject to rate the experience with use of the study drug in comparison to the prestudy pain medication regarding ease of use, convenience, frequency, pain control, and overall satisfaction. Each question was rated on a scale from 1 (extremely satisfied) to 6 (extremely dissatisfied): Q1=Satisfaction with study drug; Q2=Ease of study drug use to treat pain; Q3=Convenience of study drug to treat pain; Q4=Overall drug satisfaction managing pain; Q5=Satisfaction with frequency of use; Q6=Ease of planning study drug use. TSQ - Part I was not administered in the extension period.
- Treatment Satisfaction Questionnaire (TSQ) - Part II [ Time Frame: At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension ]The TSQ is a self-administered questionnaire that consists of 2 parts. Part II has 2 questions that measure the subject's willingness to continue the use of study drug as pain medication (Q1), and to recommend the study drug to someone else (Q2). Question 1 consists of 6 categories of response rated on a scale from 1 (very willing to continue) to 6 (very unwilling to continue): 1=Very willing to continue; 2=Willing to continue; 3=Somewhat willing to continue; 4=Somewhat unwilling to continue; 5=Unwilling to continue; 6=Very unwilling to continue. Question 2 consists of 3 categories of response: 1=yes; 2=no; 3=undecided.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400139
Show 98 Study Locations