Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A 6-Month, Open-Label, Extension Study to Evaluate the 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 Chronic Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

ClinicalTrials.gov ID

NCT01922739

Acronym / sponsor ID

C33237/3104

Conditions

Low Back Pain

Keywords

low back pain, hydrocodone bitartrate, opioids

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

182 participants (actual)

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)

Study start

Jul 2013

Primary completion

Aug 2014 (actual)

Study completion

Aug 2014 (actual)

First posted

14 Aug 2013 (estimated)

Results

Posted 2 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

18 to 80 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Participants With Adverse Events

   Time frame: Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)

   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. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. 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.

2. Participants With Potentially Clinically Significant Abnormal Laboratory Values

   Time frame: End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)

   Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values. Significance criteria: * Blood urea nitrogen: >=10.71 mmol/L * Creatinine: >=177 μmol/L * Uric acid: M>=625, F>=506 μmol/L * Aspartate aminotransferase (AST): >=3* upper limit of normal (ULN) * Alkaline phosphatase: >=3* upper limit of normal (ULN) * Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN) * Serum white blood cells: >=20 * 10^9/L * Hemoglobin: M<=115, F<=95 g/dL * Hematocrit: M<0.37, F<0.32 L/L * Eosinophils: >=10.0 % * Platelets: <=75 * 10^9/L * Absolute neutrophils: <=1.0 * 10^9/L * Urinalysis: Glucose, Ketones, and Total Protein: >=2 unit increase from baseline

3. Participants With Potentially Clinically Significant Abnormal Vital Signs Values

   Time frame: Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)

   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

4. Participants With Shifts From Normal to Abnormal in Physical Examination Findings

   Time frame: End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)

   The endpoint visit or early termination visit was an abbreviated exam. Endpoint refers to the last observation carried forward.

5. Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings

   Time frame: Baseline (final visit for study 3103), End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)

   A 12-lead ECG was conducted at the final visit for study 3103 which is used as baseline for this study, and at week 22 of the treatment period [or early termination]). A qualified physician at the study center was responsible for providing interpretation of the ECG. Endpoint refers to the last observation carried forward.

6. Participants With Clinically Significant (CS) Hearing Changes From Baseline to the Final Visit in Pure Tone Audiometry Test Results

   Time frame: Baseline was within two weeks of the final study visit in study 3103; during study exam was within two weeks of the end of trial visit for study 3104 (up to study week 26)

   Pure tone audiometry was performed by trained personnel. Hearing loss was classified in degrees of hearing from normal to profound. This classification was determined by the hearing threshold (or the softest sound detected at a specific frequency). The exact ranges that classified hearing loss depended on the exact technique used during testing and on the patient's age. These values were provided by each audiology laboratory that performed the test. For serial audiograms, the criteria for a clinically significant hearing change were based on guidance from the American Speech Language Hearing Association (ASHA 1994, cited in [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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Low Back Pain

• Not yet recruiting

  Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.

  Low Back Pain

• Not yet recruiting

  Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,

  Chronic Non Specific Mechanical Low Back Pain

• Not yet recruiting

  Comparing Non-Medicine Strategies for Improving Low Back Pain

  Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)

• Not yet recruiting

  Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain

  Nonspecific Low Back Pain

• Not yet recruiting

  Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain

  Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

61 sites in 1 country: see every site and its status.