Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

54 sites in 1 country.

About this study

Official title: A 12-Month, Open-Label Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours in Patients Who Require Opioid Treatment for an Extended Period of Time

Conditions

Chronic Pain

Being tested

Hydrocodone ER

Keywords

moderate to severe pain, diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, osteoarthritis, rheumatoid arthritis

Medical subject headings

Chronic Pain, Neuralgia, Postherpetic, Wounds and Injuries, Complex Regional Pain Syndromes, Back Pain, Neck Pain, Osteoarthritis, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Hydrocodone ERDrug

  Also called CEP-33237, Hydrocodone bitartrate extended-release

  Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours. During the open-label titration period, doses were adjusted until a stable pain control was achieved. In general, the dose of hydrocodone extended release tablets could be adjusted for efficacy or tolerability, as necessary, at any time during the open-label treatment period; however, participants were required to visit the study center before increasing the dose of study drug.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Participants With Adverse Experiences

   An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

   Measured: Day 1 of open-label titration period - Week 52 of the open-label treatment period

2. Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status

   Data represents participants with PCS abnormal serum chemistry, hematology and urinalysis values.

   Significance criteria:

   • alanine aminotransferase (ALT): >=3 times the upper limit of normal (ULN). Normal range is 6-43 U/L
   • aspartate aminotransferase (AST): >=3 times ULN. Normal range is 9-36 U/L
   • blood urea nitrogen (BUN): >=10.71 mmol/L
   • creatinine: >=177 μmol/L
   • uric acid: M>=625, F>=506 μmol/L
   • white blood cell count: <=3.0*10^9/L
   • hemoglobin: M<=115, F<=95 g/dL
   • hematocrit: M<0.37, F<0.32 L/L
   • urine blood (hemoglobin): >=2 unit increase from baseline
   • urine glucose: >=2 unit increase from baseline

   Measured: Day 1 - Week 52 of the open-label treatment period

3. Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status

   Data represents participants with potentially clinically significant (PCS) vital sign values.

   Significance criteria

   • Pulse - high: >=120 and increase of >= 15 beats/minute from baseline
   • Pulse - low: <=50 and decrease of >=15 beats/minute
   • Systolic blood pressure - high: >=180 and increase >=20 mmHg
   • Systolic blood pressure - low: <=90 and decrease >=20 mmHg
   • Diastolic blood pressure - high: >=105 and increase of >=15 mmHg
   • Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg

   Measured: Day 1 of open-label titration period - Week 52 of the open-label treatment period

4. Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status

   A 12-lead ECG was conducted at screening, week 24, and week 52 or at the last postbaseline observation. For rollover participants, the ECG performed at the final visit of study 3079 served as the 1st ECG in study 3080. A qualified physician was responsible for interpreting the ECG. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared with baseline was considered an adverse event.

   For overall results, the worst postbaseline finding for the participant was summarized.

   Results below are formatted as Baseline ECG result - Overall ECG result.

   Measured: Baseline for new participants was between Day -7 and -14 (the study 3080 screening visit); baseline for rollover participants was the last ECG in study 3079. During study ECGs were performed on weeks 24 and 52 of the open-label treatment period

5. Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status

   Pure tone audiometry was performed by trained personnel. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient's hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (Konrad-Martin et al 2005). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to "no response" at 3 consecutive test frequencies.

   Measured: Baseline for new participants was between Day -7 and -14 (study 3080 screening visit); baseline for rollover participants was the baseline test in study 3079. During study covers both open-label titration and 52-week treatment periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted19 Oct 2010 (estimated)
2. Study startOct 2010
3. Primary completionSep 2012
4. Study completionSep 2012

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Chronic PainStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.