Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chroni… (NCT01400139) | Clinical Trial Compass
CompletedPhase 3
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.
United States922 participantsStarted 2011-07
Plain-language summary
The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria include:
* Male and female subjects ≥ 18 years of age with moderate to severe, chronic nonmalignant and nonneuropathic pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to the screening visit;
* Subjects deemed by the investigator/medically qualified designee (must be MD or DO) to be appropriate candidates for the protocol specified, around the clock HYD therapeutic regimen;
* Female subjects who are premenopausal or postmenopausal less than 1 year and who have not had surgical sterilization (ie, tubal ligation, partial or complete hysterectomy) must have a negative serum pregnancy test, be nonlactating, and willing to use adequate and reliable contraception throughout the study (eg, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception);
* Subjects who are willing and able to be compliant with the protocol, are capable of subjective evaluation (ie pain scores), are able to read and understand questionnaires, are willing and able to use an electronic diary, and are able to read, understand, and sign the written informed consent form in English.
Exclusion Criteria include:
* Subjects taking opioid analgesic(s) equivalent to \> 120 mg/day of oxycodone during the 14 days prior to the screening visit;
* Subjects who previously participated in an investigational hydrocodone study within 90 days prior to the first dose of study medication ;
* Subjects who have used any i…
What they're measuring
1
The Number of Participants With Adverse Events as a Measure of Safety
Timeframe: Up to 84 weeks
2
Daily "Average Pain Over the Last 24 Hours"
Timeframe: 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)