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Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

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ClinicalTrials.gov Identifier: NCT01115569
Recruitment Status : Completed
First Posted : May 4, 2010
Results First Posted : April 25, 2014
Last Update Posted : November 9, 2022
Information provided by (Responsible Party):
UCB Pharma ( Zogenix, Inc. )

Brief Summary:
This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Hydrocodone Bitartrate Phase 3

Detailed Description:
Subjects will go through screening, an open-label conversion and titration phase of up to 6 weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Open-Label Safety Study of Hydrocodone Bitartrate Controlled-Release Capsules With Flexible Dosing to Treat Subjects With Moderate to Severe Chronic Pain
Study Start Date : May 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: Hydrocodone Bitartrate
Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.
Drug: Hydrocodone Bitartrate
Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks
Other Name: Hydrocodone Bitartrate Controlled Release (HC-CR)

Primary Outcome Measures :
  1. Mean Change in Average Daily Pain [ Time Frame: 1 year ]
    Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.

Secondary Outcome Measures :
  1. Maintenance of Efficacy [ Time Frame: 1 year ]
    Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subjects must have a diagnosed moderate to severe chronic pain condition treated with around-the-clock opioids for at least the past 3 months or in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their pain
  • Subjects must have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone
  • Subjects must be able to complete study procedures and attend clinic visits for 6 to 12 months
  • Females subjects of childbearing potential must have a negative urine pregnancy test at the Screen Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.
  • Subjects must have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition
  • Subjects must voluntarily provide written informed consent

Exclusion Criteria:

  • Any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain or increase the risk of opioid-related adverse events (AEs)
  • A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete study drug
  • A surgical procedure for pain within the last 3 months
  • Uncontrolled blood pressure, i.e., a sitting systolic blood pressure >180 mm Hg or <90 mm Hg, and/or a sitting diastolic blood pressure >120 mm Hg or <50 mm Hg at Screening
  • A body mass index (BMI) > 45 kg/m2
  • A hospital anxiety and depression scale (HADS) score of >12 in either depression or anxiety subscales or an established history of any psychiatric disorder that is poorly controlled
  • A clinically significant abnormality in clinical chemistry, hematology or urinalysis

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): NCT01115569

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Sponsors and Collaborators
Zogenix, Inc.
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Study Director: Vickie Gorgone Zogenix, Inc.
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Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT01115569    
Other Study ID Numbers: ZX002-0802
First Posted: May 4, 2010    Key Record Dates
Results First Posted: April 25, 2014
Last Update Posted: November 9, 2022
Last Verified: March 2014
Keywords provided by UCB Pharma ( Zogenix, Inc. ):
chronic pain
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents