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Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Hydrocodone ER

Placebo

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring chronic low back pain, hydrocodone bitartrate, opioids

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient has had moderate to severe chronic low back pain for at least 3 months duration before screening.
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 is willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the study center for scheduled study visits, as specified in the protocol.
The patient is 18 through 80 years of age at the time of screening.
Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception, 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. - Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. NOTE: A woman will be considered surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy.
Other criteria apply.

Exclusion Criteria:

The patient is taking a total of more than 135 mg/day of oxycodone, or equivalent, during the 14 days before screening.
The patient's primary painful condition under study is related to any source of chronic pain other than low back pain.
The patient has radicular (nerve compression) pain or another type of purely neuropathic pain.
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.
The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
Other criteria apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Hydrocodone ER

Arm Description

Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain during the titration period. During the treatment period, participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step-wise, double-blind schedule to tamper off active drug was implemented during the first 2 weeks of the 12-week, double-blind, placebo-controlled treatment period to reduce the risk of withdrawal effects in participants randomly assigned to placebo.

Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain during the titration period. During the 12-week, double-blind, placebo-controlled treatment period, participants randomly assigned to hydrocodone ER were administered tablets twice a day at the dosage deemed successful for managing their pain during the titration period.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 of the Treatment Period in Weekly Average of Daily Worst Pain Intensity (WPI)

The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their worst pain intensity over the last 24 hours. Weekly WPI scores averaged daily scores collected over the previous 7 days for each analysis visit. Negative change from baseline scores indicate improvement in pain control. The analysis included WPI data observed before discontinuation of study drug and was based on the multiple imputations (MI) method to handle missing scores at week 12. Consistent with the recommendations of the National Academy of Sciences (NAS) report (Panel on Handling Missing Data in Clinical Trials 2010), the MI method includes an assumption of missing at random (MAR) and takes into account a potential bias toward the active-drug treatment group for patients who discontinued study drug because of adverse events.

Secondary Outcome Measures

Change From Baseline to Week 12 of the Treatment Period in Weekly Average Pain Intensity (API)

The API over the last 24 hours was recorded daily by patients in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described the average pain intensity over the last 24 hours. Weekly API scores averaged daily scores collected over the previous 7 days for each analysis visit. Negative change from baseline scores indicate improvement in pain control. The analysis included API data observed before discontinuation of study drug and was based on the MI method to handle missing scores at week 12. Consistent with the recommendations of the National Academy of Sciences (NAS) report (Panel on Handling Missing Data in Clinical Trials 2010), the MI method includes an assumption of missing at random (MAR) and takes into account a potential bias toward the active-drug treatment group for patients who discontinued study drug because of adverse events.

Kaplan-Meier Estimates for Time to Loss of Efficacy

Time to loss of efficacy was defined as discontinuation of study drug for lack of efficacy or the start of excessive rescue medication while taking study drug. Excessive rescue medication usage was defined as 10 or more days of rescue medication usage in any 14 consecutive days at a total of 15 mg (hydrocodone-equivalent) or higher each day during the post 2-week tapering period of the double-blind treatment period.

Percentage of Participants With a 30% or Greater Increase in Weekly Average Pain Intensity (API) From Baseline to Week 12 Visit, and an Average API Score of 5 or Higher at Week 12

The API over the last 24 hours was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described the average pain intensity over the last 24 hours. Weekly API scores averaged daily scores collected over the previous 7 days for each analysis visit.

Change From Baseline to Final On-Treatment Visit in Roland Morris Disability Questionnaire (RMDQ) Score

The RMDQ is a patient-rated, 24-question evaluation used to assess acute disability associated with low back pain. Each question is answered with a YES or NO response, and each YES response is given 1 point. Scores on the RMDQ range from 0 to 24, with higher scores indicating greater disability. Negative change from baseline scores indicate improvement in level of disability.

Participants With Adverse Events During Open-Label Titration and Double-Blind Treatment Periods

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.

Participants With Clinically Significant Hearing Changes From Baseline to Final Assessment in Pure Tone Audiometry Test Results

Pure tone audiometry was performed by a qualified audiologist and was not done at the study center. 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.

Subjective Opiate Withdrawal Scales (SOWS) Total Scores During the Double-Blind Treatment Period

The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at week 12 or early termination. The SOWS was a self-administered questionnaire used to measure a participant's signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (such as my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.

Clinical Opiate Withdrawal Scales (COWS) Total Scores During the Double-Blind Treatment Period

COWS is a clinician-rated scale used to measure a participant's signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at weeks 1, 2, 4, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5. A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows: 0 to 4=normal 5 to 12=mild 13 to 24=moderate 25 to 36=moderately severe 36=severe

Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment 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 Alanine aminotransferase (ALT): >=3* upper limit of normal (ULN) Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN) Serum white blood cells: <=3.0 * 10^9/L Hemoglobin: M<=115, F<=95 g/dL Hematocrit: M<0.37, F<0.32 L/L Eosinophils: >=10.0 % Absolute neutrophils: <=1.0 * 10^9/L Urinalysis: Glucose: >=2 unit increase from baseline

Participants With Potentially Clinically Significant Abnormal Vital Sign Values During the Double-Blind Treatment Period

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

Participants With Potentially Clinically Significant Abnormal Electrocardiogram Findings During the Double-Blind Treatment Period

Data represents the number of participants with potentially clinically significant (PCS) electrocardiogram findings on the final study visit.

Full Information

NCT ID

NCT01789970

First Posted

February 8, 2013

Last Updated

June 2, 2017

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01789970

Brief Title

Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

Official Title

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 30 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain. Patients may be opioid-naïve or opioid-experienced.

Detailed Description

The study consisted of a screening period of approximately 7 to 14 days, an open label titration period of up to 6 weeks, and a double blind treatment period of 12 weeks. The objective of the open label titration period was to find the successful dose of hydrocodone extended release (ER) tablets that produced stable pain relief without unacceptable adverse events (AEs). Stable pain relief was defined as an average pain intensity (API) score over the previous 24 hours of 4 or less and a worst pain intensity (WPI) score of 6 or less on the 11-point numerical rating scale (NRS-11) (0=no pain to 10=worst pain imaginable) for either 4 consecutive days or 4 out of 7 consecutive days, while the same dose of study drug was maintained for up to 7 days. Scores for WPI and API were recorded daily in individual patient electronic diaries. Patients returned to the study center prior to each dose adjustment. The starting dose of hydrocodone ER tablets depended on whether the subject was opioid-naïve or opioid-experienced. Opioid-naïve participants started at a 15-mg dose of hydrocodone ER tablets every 12 hours. For opioid-experienced participants, the starting dose of hydrocodone ER tablets was to be approximately equivalent to 50% of the dose of opioid analgesic that they were receiving at screening and administered every 12 hours. Investigators switched participants from previous opioid therapy to hydrocodone ER tablets on the basis of predefined dose equivalents. Participants who met the criterion of a stabilized dose were randomly assigned into the 12 week, double-blind, placebo controlled treatment period on the final day of the open label titration period (baseline visit). Participants began treatment with double blind study drug at the effective dose of hydrocodone ER tablets achieved during the titration period or matching placebo. Rescue medication was permitted in addition to the study drug during the double blind treatment period. Participants who participated in the study in compliance with the protocol and complete 12 weeks of double-blind treatment with study drug, were considered to have completed the study and could have been eligible to enroll in a 6-month open-label study (study C32337/3104, NCT01922739).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

chronic low back pain, hydrocodone bitartrate, opioids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

625 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Hydrocodone ER

Arm Type

Experimental

Arm Description

Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain during the titration period. During the 12-week, double-blind, placebo-controlled treatment period, participants randomly assigned to hydrocodone ER were administered tablets twice a day at the dosage deemed successful for managing their pain during the titration period.

Intervention Type

Drug

Intervention Name(s)

Hydrocodone ER

Other Intervention Name(s)

CEP-33237, Hydrocodone bitartrate extended-release tablets

Intervention Description

During the open-label, titration period, all participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain. Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment arm during the double-blind treatment period at the dose level identified during the titration period. Participants were instructed to take tablets with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching the active drug dose identified during the titration period was taken by participants randomized to the placebo treatment arm during the double-blind treatment period. Participants were instructed to take intervention with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.

Primary Outcome Measure Information:

Title

Change From Baseline to Week 12 of the Treatment Period in Weekly Average of Daily Worst Pain Intensity (WPI)

Description

Time Frame

Days -6 to 0 of Treatment Period (baseline), Week 12 of Treatment Period

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 12 of the Treatment Period in Weekly Average Pain Intensity (API)

Description

Time Frame

Days -6 to 0 of Treatment Period (baseline), Week 12

Title

Kaplan-Meier Estimates for Time to Loss of Efficacy

Description

Time Frame

Day 1 to Week 12 of Treatment Period

Title

Percentage of Participants With a 30% or Greater Increase in Weekly Average Pain Intensity (API) From Baseline to Week 12 Visit, and an Average API Score of 5 or Higher at Week 12

Description

Time Frame

Days -6 to 0 of Treatment Period (baseline), Week 12

Title

Change From Baseline to Final On-Treatment Visit in Roland Morris Disability Questionnaire (RMDQ) Score

Description

Time Frame

Days 7-14 of Titration Period (baseline), Week 12 or end of study visit during the Treatment Period

Title

Participants With Adverse Events During Open-Label Titration and Double-Blind Treatment Periods

Description

Time Frame

Day 1 of Titration Period up to Week 12 of Treatment Period (maximum treatment duration was 127 days)

Title

Participants With Clinically Significant Hearing Changes From Baseline to Final Assessment in Pure Tone Audiometry Test Results

Description

Time Frame

Days 7-14 of Titration Period (baseline), Day 0 of Treatment Period (last day of Titration Period), Week 12 or end of study visit during the Treatment Period

Title

Subjective Opiate Withdrawal Scales (SOWS) Total Scores During the Double-Blind Treatment Period

Description

Time Frame

Weeks 1, 2, 4 and Endpoint of the Treatment Period

Title

Clinical Opiate Withdrawal Scales (COWS) Total Scores During the Double-Blind Treatment Period

Description

Time Frame

Weeks 1, 2, 4 and Endpoint of the Treatment Period

Title

Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period

Description

Time Frame

Day 1 up to Week 12 of the Treatment Period

Title

Participants With Potentially Clinically Significant Abnormal Vital Sign Values During the Double-Blind Treatment Period

Description

Time Frame

Day 1 to Week 12 of the Treatment Period

Title

Participants With Potentially Clinically Significant Abnormal Electrocardiogram Findings During the Double-Blind Treatment Period

Description

Data represents the number of participants with potentially clinically significant (PCS) electrocardiogram findings on the final study visit.

Time Frame

Final study visit (week 12 or end of treatment visit)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient has had moderate to severe chronic low back pain for at least 3 months duration before screening. 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 is willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the study center for scheduled study visits, as specified in the protocol. The patient is 18 through 80 years of age at the time of screening. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception, 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. - Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. NOTE: A woman will be considered surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy. Other criteria apply. Exclusion Criteria: The patient is taking a total of more than 135 mg/day of oxycodone, or equivalent, during the 14 days before screening. The patient's primary painful condition under study is related to any source of chronic pain other than low back pain. The patient has radicular (nerve compression) pain or another type of purely neuropathic pain. 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. The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. Other criteria apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Project Leader

Organizational Affiliation

Teva GCO

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 10416

City

Anniston

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 10382

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 10403

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 10412

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 10426

City

Mobile

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 10436

City

Montgomery

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 10363

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Teva Investigational Site 10366

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Teva Investigational Site 10437

City

Tucson

State/Province

Arizona

Country

United States

Facility Name

Teva Investigational Site 10358

City

Anaheim

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10408

City

Bell Gardens

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10425

City

Carmichael

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10390

City

Cerritos

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10429

City

El Cajon

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10423

City

Escondido

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10740

City

Garden Grove

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10391

City

Huntington Park

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10422

City

La Jolla

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10413

City

Laguna Hills

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10442

City

Laguna Hills

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10370

City

Los Angeles

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10392

City

Sherman Oaks

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10398

City

Thousand Oaks

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10428

City

Torrance

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10361

City

Walnut Creek

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10441

City

Waterbury

State/Province

Connecticut

Country

United States

Facility Name

Teva Investigational Site 10369

City

DeLand

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10744

City

Edgewater

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10379

City

Fort Lauderdale

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10365

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10445

City

Leesburg

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10362

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10381

City

Ormond Beach

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12036

City

Pembroke Pines

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10357

City

Plantation

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10367

City

Royal Palm Beach

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10435

City

Royal Palm Beach

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10742

City

Sanford

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10432

City

Columbus

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10383

City

Marietta

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10385

City

Marietta

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10444

City

Newnan

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10431

City

Meridian

State/Province

Idaho

Country

United States

Facility Name

Teva Investigational Site 10743

City

Meridian

State/Province

Idaho

Country

United States

Facility Name

Teva Investigational Site 10411

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Teva Investigational Site 10418

City

Avon

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 10380

City

Evansville

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 10440

City

Newburgh

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 10375

City

Overland Park

State/Province

Kansas

Country

United States

Facility Name

Teva Investigational Site 10419

City

New Orleans

State/Province

Louisiana

Country

United States

Facility Name

Teva Investigational Site 10359

City

Shreveport

State/Province

Louisiana

Country

United States

Facility Name

Teva Investigational Site 10389

City

Fall River

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 10388

City

Bay City

State/Province

Michigan

Country

United States

Facility Name

Teva Investigational Site 10397

City

Biloxi

State/Province

Mississippi

Country

United States

Facility Name

Teva Investigational Site 10406

City

Hazelwood

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 10401

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 10376

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

Teva Investigational Site 10396

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

Teva Investigational Site 10417

City

Henderson

State/Province

Nevada

Country

United States

Facility Name

Teva Investigational Site 10399

City

Las Vegas

State/Province

Nevada

Country

United States

Facility Name

Teva Investigational Site 10409

City

Berlin

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 10439

City

Buffalo

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 10394

City

New York

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 10407

City

New York

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 10410

City

New York

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 10443

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 10414

City

Winston-Salem

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 10446

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10415

City

Altoona

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 10430

City

Duncansville

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 10386

City

Mechanicsburg

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 10373

City

Tipton

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 10404

City

North Charleston

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 10741

City

Spartanburg

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 10405

City

Austin

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10364

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10372

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10395

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10371

City

Houston

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 12035

City

Houston

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10377

City

Lake Jackson

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10374

City

Plano

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10378

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10402

City

Salt Lake City

State/Province

Utah

Country

United States

Facility Name

Teva Investigational Site 10438

City

Roanoke

State/Province

Virginia

Country

United States

Facility Name

Teva Investigational Site 10420

City

Bellevue

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 10433

City

Everett

State/Province

Washington

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

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Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

Low Back Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial