Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
CompletedPhase 2NCT01096966
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.
Study details
- Official title
- A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Bupivacaine TTS (Bupivacaine Patch) in Patients With Chronic Low Back Pain
- Conditions
- Interventions
- Drug: Bupivacaine TTS (Bupivacaine Patch)
- Drug: Placebo patch
- Sponsor
- Durect
- Collaborators
- Pfizer
- Start date
- 2010-03
- Primary completion
- 2011-02
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 21
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Diagnosis of chronic low back pain for more than 3 months 2. If taking non-steroidal anti-inflammatory drugs or non-opioid analgesics, must be on a regular, scheduled dose for at least 4 weeks prior to the first visit and intend to remain on a stable dose of these agents for the study duration 3. Pain intensity score greater than or equal to 5 out of 10 at the first visit 4. Able to apply patches at home 5. Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study 6. Females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study Exclusion Criteria: 1. History of, or ongoing, alcohol or drug abuse 2. Positive drug test for alcohol, illicit drug use or opioids 3. Primary diagnosis of chronic low back pain due to neuropathic pain 4. History of back surgery or plan for back surgery 5. Use of opioids within 2 weeks of the first visit and during the study 6. Previous ineffective use of lidocaine patches 7. Morbid obesity 8. Moderate or severe depression 9. An open skin lesion within the painful area where patches will be applied 10. Patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain 11. Pregnant or breastfeeding females
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01096966