Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:05 AM
Study NCT ID:
NCT01096966
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2010-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'dispFirstSubmitDate': '2011-08-16', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2010-03-30', 'dispFirstSubmitQcDate': '2011-08-16', 'studyFirstSubmitQcDate': '2010-03-30', 'dispFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)', 'timeFrame': 'baseline to 12 weeks after baseline'}], 'secondaryOutcomes': [{'measure': 'Subjects achieving 20% pain relief at 12 weeks compared to baseline', 'timeFrame': 'baseline to 12 weeks after baseline'}, {'measure': "Subjects 'much improved' or 'very much improved' at 12 weeks", 'timeFrame': '12 weeks after baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic low back pain'], 'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of chronic low back pain for more than 3 months\n2. 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\n3. Pain intensity score greater than or equal to 5 out of 10 at the first visit\n4. Able to apply patches at home\n5. Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study\n6. Females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study\n\nExclusion Criteria:\n\n1. History of, or ongoing, alcohol or drug abuse\n2. Positive drug test for alcohol, illicit drug use or opioids\n3. Primary diagnosis of chronic low back pain due to neuropathic pain\n4. History of back surgery or plan for back surgery\n5. Use of opioids within 2 weeks of the first visit and during the study\n6. Previous ineffective use of lidocaine patches\n7. Morbid obesity\n8. Moderate or severe depression\n9. An open skin lesion within the painful area where patches will be applied\n10. Patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain\n11. Pregnant or breastfeeding females'}, 'identificationModule': {'nctId': 'NCT01096966', 'briefTitle': 'Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Durect'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'K843-09-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine TTS', 'interventionNames': ['Drug: Bupivacaine TTS (Bupivacaine Patch)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo patch', 'interventionNames': ['Drug: Placebo patch']}], 'interventions': [{'name': 'Bupivacaine TTS (Bupivacaine Patch)', 'type': 'DRUG', 'description': 'Contains bupivacaine base, in a flexible and rectangular-shaped, transdermal, delivery system. Three patches applied to the lower back every 72 hours for 12 weeks.', 'armGroupLabels': ['Bupivacaine TTS']}, {'name': 'Placebo patch', 'type': 'DRUG', 'description': 'Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.', 'armGroupLabels': ['Placebo patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33306', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30265', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '01103', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10004', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '73109', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Paul Meisner, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'King Pharmaceuticals is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Durect', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}