Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01240863
First received: November 10, 2010
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

The primary objective of this study is to evaluate efficacy of hydrocodone extended-release tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12.


Condition Intervention Phase
Pain
Drug: Hydrocodone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change in the weekly Average Pain Intensity (API) [ Time Frame: change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    Weekly Average Pain Intensity (API) based on the 11-point Numerical Rating Scale (NRS-11) from electronic diary


Secondary Outcome Measures:
  • Percentage of patients who withdraw from the study [ Time Frame: during the 12-week double-blind treatment period ] [ Designated as safety issue: No ]
  • Time from baseline to patient withdrawal from the study [ Time Frame: during the 12-week double-blind treatment period ] [ Designated as safety issue: No ]
  • Weekly average of daily API scores [ Time Frame: at weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Based on the 11-point Numerical Rating Scale (NRS-11) from electronic diary

  • Weekly average of daily Worst Pain Intensity (WPI) [ Time Frame: at weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Based on NRS-11 from electronic diary

  • Weekly API increase from baseline exceeding 33% and 50% [ Time Frame: during the 12-week double-blind treatment period ] [ Designated as safety issue: No ]
  • Rescue medication usage [ Time Frame: during the first 2 weeks of the 12-week double-blind treatment period ] [ Designated as safety issue: No ]
    - first time frame regarding Rescue medication usage

  • Rescue medication usage [ Time Frame: after the first 2 weeks of the 12-week double-blind treatment period ] [ Designated as safety issue: No ]
    - second time frame regarding Rescue medication usage

  • Clinician Assessment of Patient Function (CAPF) ratings [ Time Frame: at weeks 4, 8, and 12 or last postbaseline observation ] [ Designated as safety issue: No ]
  • Patient Assessment of Function (PAF) ratings [ Time Frame: at weeks 4, 8, and 12 or last postbaseline observation ] [ Designated as safety issue: No ]
  • Clinician Global Impression of Severity of Illness (CGI-S) ratings in regard to pain [ Time Frame: at weeks 1, 2, 4, 8, and 12 or last postbaseline observation ] [ Designated as safety issue: No ]
  • Brief Pain Inventory-Short Form (BPI-SF) scores [ Time Frame: at weeks 1, 2, 4, 8, and 12 or last postbaseline observation ] [ Designated as safety issue: No ]
  • 36-Item Short Form Health Survey (SF-36) scores [ Time Frame: at week 12 or last postbaseline observation ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of hydrocodone extended-release tablets [ Time Frame: during the 12-week double-blind treatment period ] [ Designated as safety issue: Yes ]
    • adverse events, vital signs, and concomitant medication
    • physical exam findings and clinical lab test results at week 12
    • pure tone audiometry at titration, at baseline, and at week 12
    • Subjective Opiate Withdrawal Scale (SOWS) scores, daily during the first 4 weeks, then at weeks 8 and 12
    • Clinical Opiate Withdrawal Scale (COWS) scores at weeks 1, 2, 4, 8, and 12
    • Addiction Behavior Checklist (ABC) scores at titration and at weeks 1, 4, 8, and 12
    • Current Opioid Misuse Measure (COMM) scores at titration and at weeks 1, 4, 8, and 12
    • electrocardiograms (ECGs) at week 12


Enrollment: 391
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrocodone Drug: Hydrocodone
Hydrocodone at 15 to 90 mg, administered every 12 hours
Placebo Comparator: Placebo Drug: Placebo
Matching Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is able to speak English and is willing to provide written informed consent, including a written opioid agreement, to participate in this study.
  • The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol.
  • Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study, and have a negative pregnancy test at screening.
  • The patient has pain of at least 3 months' duration associated with osteoarthritis or low back pain.
  • The patient reports an average pain intensity score, over the prior 24 hours, of 5 or more on the NRS-11.
  • If the patient is receiving physical therapy, biofeedback therapy, acupuncture therapy, or herbal remedies, these therapies must remain unchanged during the study.
  • The patient must not participate in other study involving an investigational agent while enrolled into the present study.

Exclusion Criteria:

  • The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug.
  • The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse with the exception of nicotine or caffeine.
  • The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
  • The patient is taking a total (ie, around-the-clock plus rescue medication) of more than 135 mg/day of oxycodone, or equivalent, during the 14 days prior to screening.
  • The patient has a history of suicidality.
  • The patient is expected to have surgery during the study.
  • The patient's primary painful condition under study is related to any source of chronic pain other than osteoarthritis or low back pain.
  • The patient is pregnant or lactating.
  • The patient has active malignancy.
  • The patient has human immunodeficiency virus (HIV).
  • In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination and/or clinical laboratory test values.
  • The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with opioids.
  • The patient has participated in a study involving an investigational drug in the previous 30 days.
  • The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
  • The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.
  • The patient is involved in active litigation in regard to the pain currently being treated.
  • The patient has a positive urine drug screen (UDS) that is not medically explainable.
  • The investigator feels that the patient is not suitable for the study for any reason.
  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: NCT01240863

  Show 73 Study Locations
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert, MD Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01240863     History of Changes
Other Study ID Numbers: C33237/3079
Study First Received: November 10, 2010
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
osteoarthritis
low back pain
Moderate to Severe Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Rheumatic Diseases
Signs and Symptoms
Hydrocodone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014