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

NCT ID: NCT01922739

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-08-31

Brief Summary

This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe chronic low back pain who require continuous opioid treatment for an extended period of time.

To be eligible for Study 3104, patients were required to have completed the entire double blind treatment period on study drug (either placebo or hydrocodone bitartrate ER tablets) through week 12 of Study 3103 (NCT01789970) and to have met the entry criteria for Study 3104.

Detailed Description

Eligible patients from Study 3103 (NCT01789970) were enrolled for participation in this extension study. For these patients, the final study visit in Study 3103 was visit 1 for this study (also referred to as the titration or adjustment baseline visit, depending on whether the patient was enrolled under the original or amended protocol, respectively). The original protocol was amended after 26 patients had been enrolled in the study. Those who were enrolled under the original protocol participated in a double-blind titration period of up to approximately 4 weeks followed by an open-label treatment period of 22 weeks. Those patients who were enrolled under the amended protocol participated in an open-label adjustment period of up to approximately 3 weeks followed by an open-label treatment period of 22 weeks.

Conditions

Low Back Pain

Keywords

low back pain; hydrocodone bitartrate; opioids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydrocodone ER

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. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.

Group Type: EXPERIMENTAL

Hydrocodone ER

Intervention Type: DRUG

Participants were instructed to take hydrocodone ER tablets orally with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.

Placebo

Intervention Type: DRUG

During the double-blind titration period used in the original protocol, placebo tablets matching each dose of hydrocodone bitartrate ER tablets (active drug) were used to maintain the blind but not for purposes of comparison.

Interventions

Hydrocodone ER

Participants were instructed to take hydrocodone ER tablets orally with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.

Intervention Type: DRUG

Placebo

During the double-blind titration period used in the original protocol, placebo tablets matching each dose of hydrocodone bitartrate ER tablets (active drug) were used to maintain the blind but not for purposes of comparison.

Intervention Type: DRUG

Other Intervention Names

CEP-33237; Hydrocodone bitartrate extended-release tablets

Eligibility Criteria

Inclusion Criteria

1. Patients must have participated in and completed the entire double-blind treatment period on study drug through the final study visit (week 12) of study 3103.

NOTE: Patients who had a final on-treatment visit (i.e. prior to week 12) are not permitted to participate in study 3104.

2. The patient is able to speak English and is willing to provide written informed consent for study 3104, including re-signing a written opioid agreement, to participate in this study.

3. 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.

4. The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, and return to the study center for scheduled study visits, as specified in the protocol.

5. The patient must not participate in any other study involving an investigational agent (excluding those who participated in study 3103) while enrolled in the present study.

Exclusion Criteria

1. The patient's current source of pain is different from the low back pain the patient was experiencing at entry into study 3103. NOTE: Any additional source of pain for a patient must be discussed with the medical monitor.

2. The patient has current evidence of alcohol or other substance abuse with the exception of nicotine or caffeine.

3. The patient has developed, during study 3103, a medical or psychiatric disease (including suicidality) that, in the opinion of the investigator, would compromise collected data.

4. The patient is expected to have surgery during the study.

5. The patient is pregnant or lactating.

6. The patient has developed an active malignancy (excluding basal cell carcinoma) during study 3103.

7. The patient has known human immunodeficiency virus (HIV).

8. 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.

9. The patient has developed cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with opioids.

10. The patient is receiving a monoamine oxidase inhibitor (MAOI).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 10412

Birmingham, Alabama, United States

Teva Investigational Site 10426

Mobile, Alabama, United States

Teva Investigational Site 10436

Montgomery, Alabama, United States

Teva Investigational Site 10363

Phoenix, Arizona, United States

Teva Investigational Site 10366

Phoenix, Arizona, United States

Teva Investigational Site 10437

Tucson, Arizona, United States

Teva Investigational Site 10358

Anaheim, California, United States

Teva Investigational Site 10408

Bell Gardens, California, United States

Teva Investigational Site 10425

Carmichael, California, United States

Teva Investigational Site 10390

Cerritos, California, United States

Teva Investigational Site 10429

El Cajon, California, United States

Teva Investigational Site 10423

Escondido, California, United States

Teva Investigational Site 10391

Huntington Park, California, United States

Teva Investigational Site 10370

Los Angeles, California, United States

Teva Investigational Site 10392

Sherman Oaks, California, United States

Teva Investigational Site 10398

Thousand Oaks, California, United States

Teva Investigational Site 10428

Torrance, California, United States

Teva Investigational Site 10361

Walnut Creek, California, United States

Teva Investigational Site 10369

DeLand, Florida, United States

Teva Investigational Site 10379

Fort Lauderdale, Florida, United States

Teva Investigational Site 10365

Jacksonville, Florida, United States

Teva Investigational Site 10445

Leesburg, Florida, United States

Teva Investigational Site 10362

Orlando, Florida, United States

Teva Investigational Site 10381

Ormond Beach, Florida, United States

Teva Investigational Site 10357

Plantation, Florida, United States

Teva Investigational Site 10435

Royal Palm Beach, Florida, United States

Teva Investigational Site 10432

Columbus, Georgia, United States

Teva Investigational Site 10383

Marietta, Georgia, United States

Teva Investigational Site 10385

Marietta, Georgia, United States

Teva Investigational Site 10444

Newnan, Georgia, United States

Teva Investigational Site 10431

Meridian, Idaho, United States

Teva Investigational Site 10743

Meridian, Idaho, United States

Teva Investigational Site 10411

Chicago, Illinois, United States

Teva Investigational Site 10440

Newburgh, Indiana, United States

Teva Investigational Site 10419

New Orleans, Louisiana, United States

Teva Investigational Site 10359

Shreveport, Louisiana, United States

Teva Investigational Site 10389

Fall River, Massachusetts, United States

Teva Investigational Site 10388

Bay City, Michigan, United States

Teva Investigational Site 10397

Biloxi, Mississippi, United States

Teva Investigational Site 10406

Hazelwood, Missouri, United States

Teva Investigational Site 10401

St Louis, Missouri, United States

Teva Investigational Site 10376

Omaha, Nebraska, United States

Teva Investigational Site 10399

Las Vegas, Nevada, United States

Teva Investigational Site 10409

Berlin, New Jersey, United States

Teva Investigational Site 10439

Buffalo, New York, United States

Teva Investigational Site 10410

New York, New York, United States

Teva Investigational Site 10414

Winston-Salem, North Carolina, United States

Teva Investigational Site 10446

Oklahoma City, Oklahoma, United States

Teva Investigational Site 10430

Duncansville, Pennsylvania, United States

Teva Investigational Site 10386

Mechanicsburg, Pennsylvania, United States

Teva Investigational Site 10373

Tipton, Pennsylvania, United States

Teva Investigational Site 10405

Austin, Texas, United States

Teva Investigational Site 10364

Dallas, Texas, United States

Teva Investigational Site 10372

Dallas, Texas, United States

Teva Investigational Site 10371

Houston, Texas, United States

Teva Investigational Site 10377

Lake Jackson, Texas, United States

Teva Investigational Site 10374

Plano, Texas, United States

Teva Investigational Site 10378

San Antonio, Texas, United States

Teva Investigational Site 10402

Salt Lake City, Utah, United States

Teva Investigational Site 10420

Bellevue, Washington, United States

Teva Investigational Site 10433

Everett, Washington, United States

Countries

United States

Other Identifiers

C33237/3104

Identifier Type: -

Identifier Source: org_study_id