Phase 3
Completed N=625
Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain
Source: ClinicalTrials.gov NCT01789970 ↗Enrolled (actual)
625
Serious AEs
1.6%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline to Week 12 of the Treatment Period in Weekly Average of Daily Worst Pain Intensity (WPI) — 0.71; 0.07 units on a scale — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 of the Treatment Period in Weekly Average of Daily Worst Pain Intensity (WPI) |
0.71; 0.07 | <0.001 sig |
| SECONDARY Change From Baseline to Week 12 of the Treatment Period in Weekly Average Pain Intensity (API) |
0.57; 0.02 | <0.001 sig |
| SECONDARY Kaplan-Meier Estimates for Time to Loss of Efficacy |
NA; NA | 0.059 |
| SECONDARY 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 |
18.8; 12.5; 36.1; 21.1; 24.1; 16.4 | 0.0293 sig |
| SECONDARY Change From Baseline to Final On-Treatment Visit in Roland Morris Disability Questionnaire (RMDQ) Score |
-1.9; -1.5 | 0.557 |
| SECONDARY Participants With Adverse Events During Open-Label Titration and Double-Blind Treatment Periods |
196; 117; 88; 106; 13; 5 | — |
| SECONDARY Participants With Clinically Significant Hearing Changes From Baseline to Final Assessment in Pure Tone Audiometry Test Results |
29; 10; 8; 13; 5; 2 | — |
| SECONDARY Subjective Opiate Withdrawal Scales (SOWS) Total Scores During the Double-Blind Treatment Period |
6.9; 6.6; 5.1; 5.1; 5.0; 5.5 | — |
| SECONDARY Clinical Opiate Withdrawal Scales (COWS) Total Scores During the Double-Blind Treatment Period |
0.9; 0.8; 0.8; 0.7; 0.8; 0.6 | — |
| SECONDARY Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period |
3; 1; 0; 1; 3; 4 | — |
| SECONDARY Participants With Potentially Clinically Significant Abnormal Vital Sign Values During the Double-Blind Treatment Period |
2; 1; 1; 1; 1; 2 | — |
| SECONDARY Participants With Potentially Clinically Significant Abnormal Electrocardiogram Findings During the Double-Blind Treatment Period |
2; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01789970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.