Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01400139
First received: July 20, 2011
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Chronic Nonmalignant and Nonneuropathic Pain
Drug: Hydrocodone bitartrate q24h film-coated tablets
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • The number of participants with adverse events as a measure of safety [ Time Frame: Up to 84 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Daily "Average Pain Over the Last 24 Hours" [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • "Pain Right Now" Score [ Time Frame: Predose and every evening up to Week 12 ] [ Designated as safety issue: No ]
  • Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) [ Time Frame: Up to 45 days in titration and up to 52 weeks in maintenance, and up to 24 weeks in extension ] [ Designated as safety issue: No ]
  • Brief Pain Inventory Short Form (BPI-SF) [ Time Frame: Up to 52 weeks in maintenance and up to 24 weeks in extension ] [ Designated as safety issue: No ]
  • Medical Outcomes Study 36-item Short Form (SF-36) [ Time Frame: Up to 52 weeks in maintenance and up to 24 weeks in extension ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: At Week 52 in maintenance and at Week 24 in extension ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Survey [ Time Frame: At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension ] [ Designated as safety issue: No ]

Enrollment: 922
Study Start Date: July 2011
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 investigational medication other than hydrocodone within 30 days prior to the first dose of study drug;
  • Subjects with any history of seizures (subjects with history of pediatric febrile seizures may participate in the study) or increase in intracranial pressure;
  • Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder (subjects with controlled depression or other psychiatric disorder must be on a stable medication for ≥ 1 month prior to the screening visit to participate in the study);
  • Subjects with a history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time;
  • Subjects with clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling pacemaker;
  • Subjects with unstable respiratory disease that, in the opinion of the investigator, precludes entry into this study;
  • Subjects with biliary tract disease, hypothyroidism, adrenal cortical insufficiency, or any other medical condition that, in the opinion of the investigator, is inadequately treated and precludes entry into the study;
  • Subjects with history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated;
  • Subjects with evidence of impaired liver function upon entry into the study (laboratory test values ≥ 3 times the upper limit of the laboratory reference (normal) range (ULN) for aspartate transaminase [AST/SGOT] or alanine transaminase [ALT/SGPT], or values > 2 times the ULN for alkaline phosphatase), or total bilirubin level > 1.5 times the ULN or, in the opinion of the investigator/medically qualified designee (must be MD or DO), liver function impairment to the extent that the subject should not participate in this study;
  • Subjects with evidence of impaired kidney function upon entry into the study (ie, serum creatinine ≥ 2.5 mg/dL);
  • Subjects with any condition in which opioids are contraindicated, eg, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, or paralytic ileus;
  • Subjects who are allergic to hydrocodone or who have a history of allergies to other opioids. This does not include subjects who have experienced common opioid side effects (eg, nausea, constipation);
  • Subjects receiving monoamine oxidase inhibitors (MAOIs) or who have been taking MAOIs within 2 weeks of the screening visit.

Other protocol-specific inclusion/exclusion criteria may apply.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400139

  Show 98 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
  More Information

No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01400139     History of Changes
Other Study ID Numbers: HYD3003
Study First Received: July 20, 2011
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Pain
Nonmalignant pain
Nonneuropathic Pain
Opioid

Additional relevant MeSH terms:
Hydrocodone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on July 29, 2014