- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00058357
Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery
The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study
RATIONALE: A lidocaine patch may be effective in relieving numbness, tingling, and other symptoms of neuropathy. It is not yet known whether a lidocaine patch is effective in treating neuropathy in patients who have undergone surgery for cancer.
PURPOSE: This randomized phase III trial is studying lidocaine patch to see how well it works compared to a placebo patch in relieving numbness, tingling, and other symptoms of neuropathy in patients who have undergone surgery for cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine whether a lidocaine patch vs placebo improves postsurgical neuropathic pain in cancer patients.
- Compare the toxic effects of these regimens in these patients.
- Compare the effect of these regimens on mood states, functional abilities, and overall quality of life of these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to etiology of pain (breast surgery vs lung surgery vs amputation vs other), duration of pain (1-3 months vs 4-6 months vs more than 6 months), and current analgesic regimen (opioids [including tramadol] vs antidepressants vs anticonvulsants vs combination vs other vs none). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive a lidocaine transdermal patch (up to 3 patches) applied directly to the painful area for 18 hours once daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity. At the end of week 4, patients cross over to arm II.
- Arm II: Patients receive a placebo transdermal patch applied to the painful area as in arm I. At the end of week 4, patients cross over to arm I.
Pain and quality of life are assessed at baseline and weeks 4 and 8.
Patients are followed at 3-7 days.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic Scottsdale
-
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District of Columbia
-
Washington, District of Columbia, United States, 20017
- Providence Hospital
-
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic - Jacksonville
-
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Georgia
-
Augusta, Georgia, United States, 30912
- MBCCOP-Medical College of Georgia Cancer Center
-
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Illinois
-
Aurora, Illinois, United States, 60507
- Rush-Copley Cancer Care Center
-
Bloomington, Illinois, United States, 61701
- St. Joseph Medical Center
-
Canton, Illinois, United States, 61520
- Graham Hospital
-
Carthage, Illinois, United States, 62321
- Memorial Hospital
-
Eureka, Illinois, United States, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, United States, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, United States, 61401
- Galesburg Clinic
-
Havana, Illinois, United States, 62644
- Mason District Hospital
-
Hopedale, Illinois, United States, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates, Limited - West
-
Kewanee, Illinois, United States, 61443
- Kewanee Hospital
-
Macomb, Illinois, United States, 61455
- Mcdonough District Hospital
-
Normal, Illinois, United States, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, United States, 61761
- Community Cancer Center
-
Ottawa, Illinois, United States, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, United States, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, United States, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, United States, 61614
- Proctor Hospital
-
Peoria, Illinois, United States, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, United States, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, United States, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, United States, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, United States, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, United States, 61362
- St. Margaret's Hospital
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, United States, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Michigan City, Indiana, United States, 46360
- Saint Anthony Memorial Health Centers
-
Richmond, Indiana, United States, 47374
- Reid Hospital & Health Care Services, Incorporated
-
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Iowa
-
Cedar Rapids, Iowa, United States, 52402
- St. Luke's Hospital
-
Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids, Iowa, United States, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
-
Des Moines, Iowa, United States, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, United States, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, United States, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, United States, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50307
- Mercy Capitol Hospital
-
Des Moines, Iowa, United States, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Sioux City, Iowa, United States, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, United States, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, United States, 51104
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates
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West Des Moines, Iowa, United States, 50266
- Medical Oncology and Hematology Associates - West Des Moines
-
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Kansas
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Chanute, Kansas, United States, 66720
- Cancer Center of Kansas, P.A. - Chanute
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Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas, P.A. - El Dorado
-
Kingman, Kansas, United States, 67068
- Cancer Center of Kansas, P.A. - Kingman
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Liberal, Kansas, United States, 67901
- Southwest Medical Center
-
Newton, Kansas, United States, 67114
- Cancer Center of Kansas, P.A. - Newton
-
Parsons, Kansas, United States, 67357
- Cancer Center of Kansas, P.A. - Parsons
-
Pratt, Kansas, United States, 67124
- Cancer Center of Kansas, P.A. - Pratt
-
Salina, Kansas, United States, 67042
- Cancer Center of Kansas, P.A. - Salina
-
Wellington, Kansas, United States, 67152
- Cancer Center of Kansas, P.A. - Wellington
-
Wichita, Kansas, United States, 67214
- CCOP - Wichita
-
Wichita, Kansas, United States, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Wichita, Kansas, United States, 67214
- Cancer Center of Kansas, P.A. - Wichita
-
Wichita, Kansas, United States, 67203
- Associates in Womens Health, P.A. - North Review
-
Wichita, Kansas, United States, 67208
- Cancer Center of Kansas, P.A. - Medical Arts Tower
-
Winfield, Kansas, United States, 67156
- Cancer Center of Kansas, P.A. - Winfield
-
-
Michigan
-
Adrian, Michigan, United States, 49221
- Hickman Cancer Center at Bixby Medical Center
-
Lambertville, Michigan, United States, 48144
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
-
Monroe, Michigan, United States, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, United States, 48162
- Mercy Memorial Hospital System
-
-
Minnesota
-
Alexandria, Minnesota, United States, 56308
-
Brainerd, Minnesota, United States, 56401
- Brainerd Medical Center
-
Brainerd, Minnesota, United States, 56401
- St. Joseph's Medical Center
-
Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, United States, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Duluth, Minnesota, United States, 55805
- CCOP - Duluth
-
Duluth, Minnesota, United States, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, United States, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, United States, 56537
-
Fridley, Minnesota, United States, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson, Minnesota, United States, 55350
- Hutchinson Area Health Care
-
Lichfield, Minnesota, United States, 55355
- Meeker County Memorial Hospital
-
Maplewood, Minnesota, United States, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center - Minneapolis
-
Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
-
Montevideo, Minnesota, United States, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, United States, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, United States, 56303
- Coborn Cancer Center
-
Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, United States, 55379
- Saint Francis Cancer Center
-
St Paul, Minnesota, United States, 55102
- St. Joseph's Hospital
-
St. Cloud, Minnesota, United States, 56303
- CentraCare Clinic - River Campus
-
St. Louis Park, Minnesota, United States, 55416
- Park Nicollet Health Services
-
St. Paul, Minnesota, United States, 55102
- United Hospital
-
St. Paul, Minnesota, United States, 55101
- Regions Hospital Cancer Care Center
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, United States, 55125
- Woodwinds Health Campus
-
-
Montana
-
Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, United States, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, United States, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, United States, 59101
- St. Vincent Healthcare
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Billings, Montana, United States, 59107-7000
- Deaconess Billings Clinic - Downtown
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Billings, Montana, United States, 59107-5100
- Deaconess Billings Clinic Cancer Center
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Bozeman, Montana, United States, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, United States, 59715
- Internal Medicine Associates of Bozeman
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Butte, Montana, United States, 59701
- St. James Community Hospital
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Great Falls, Montana, United States, 59405
- Sletten Regional Cancer Institute
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Helena, Montana, United States, 59601
- St. Peter's Hospital
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Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, United States, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, United States, 59901
- Kalispell Medical Oncology
-
Miles City, Montana, United States, 59301
- Eastern Montana Cancer Center
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Missoula, Montana, United States, 59801
- Community Medical Center
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Missoula, Montana, United States, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, United States, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
North Carolina
-
Rutherfordton, North Carolina, United States, 28139
- Rutherford Hospital
-
-
North Dakota
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Bismarck, North Dakota, United States, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, United States, 58501
- Cancer Care Center at Medcenter One Hospital
-
Bismarck, North Dakota, United States, 58501
- Mid Dakota Clinic, P. C.
-
Bismarck, North Dakota, United States, 58502
- St. Alexius Medical Center
-
-
Ohio
-
Bowling Green, Ohio, United States, 43402
- Wood County Oncology Center
-
Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, United States, 45405
- Grandview Hospital
-
Dayton, Ohio, United States, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, United States, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, United States, 45429
- CCOP - Dayton
-
Findlay, Ohio, United States, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, United States, 43420
- Fremont Memorial Hospital
-
Kenton, Ohio, United States, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, United States, 45429
- Charles F. Kettering Memorial Hospital
-
Lima, Ohio, United States, 45804
- Lima Memorial Hospital
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Maumee, Ohio, United States, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, United States, 43537
- St. Luke's Hospital
-
Middletown, Ohio, United States, 45044
- Middletown Regional Hospital
-
Oregon, Ohio, United States, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, United States, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, United States, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, United States, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, United States, 43560
- Promedica Cancer Center at Flower Hospital
-
Tiffin, Ohio, United States, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, United States, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, United States, 43606
- Toledo Hospital
-
Toledo, Ohio, United States, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, United States, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, United States, 43623
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, United States, 43623
- Toledo Surgical Specialists
-
Troy, Ohio, United States, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, United States, 43567
- Fulton County Health Center
-
Wright-Patterson Afb, Ohio, United States, 45433-5529
- United States Air Force Medical Center Wright-Patterson
-
Xenia, Ohio, United States, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, United States, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, United States, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, United States, 57105
- Medical X-Ray Center, PC
-
-
Wyoming
-
Sheridan, Wyoming, United States, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Underwent surgical procedure for cancer diagnosis or treatment
Experiencing persistent pain for at least 1 month
- Pain must have neuropathic features (e.g., burning, shooting, stabbing, tingling, or pain from light touch)
- Anatomically related to the surgical site and compatible with nerve injury
- Pain rating of at least 4 out of 10 on the pain scale
- No pain of multiple etiologies at the proposed treatment site (e.g., pain of neuropathic and muscular or skeletal origin)
- Painful area must be no larger than can be covered by 3 lidocaine patches* NOTE: *Each patch size is 5.5 x 4 inches
- No skin disease, breakdown, infection, or extreme thinning at the site of pain
- No skin or soft tissue malignancy in the painful area
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- At least 6 months
Hematopoietic
- Not specified
Hepatic
- AST ≤ 2 times upper limit of normal
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to understand and complete questionnaires
- No recent history of or concurrent drug or alcohol abuse
- No mental or psychiatric condition that would preclude giving informed consent
- No history of allergic reaction or intolerance to lidocaine or other amide local anesthetics (e.g., bupivacaine)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior neurotoxic chemotherapy* with pain in the same area as postsurgical neuropathic pain, except for pain that was present before neurotoxic chemotherapy administration
- No concurrent neurotoxic chemotherapy* NOTE: *Including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., cisplatin or carboplatin), or vinca alkaloids (e.g., vincristine or vinblastine)
Endocrine therapy
- More than 7 days since prior topical corticosteroids to the painful area
- No new corticosteroids may be initiated during study participation
Radiotherapy
- No concurrent radiotherapy to the painful area
Surgery
- See Disease Characteristics
Other
- More than 7 days since other prior topical medications to the painful area (including capsaicin)
- No change in current analgesic regimen within the past 10 days
No new analgesic or adjuvant drugs (e.g., antidepressants, anticonvulsants, or anxiolytics) may be initiated during study participation
- Concurrent stable doses of nonopioid, opioid, and adjuvant analgesic drugs are allowed (including antidepressants or anticonvulsants)
- No concurrent class I antiarrhythmic drugs (e.g., tocainide and mexiletine)
- Concurrent skin lubricants and sunscreen are allowed provided they are not heavily applied
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lidocaine patch
Participants will be instructed to apply a patch or patches (up to 3 maximum simultaneously) directly to the affected area.
The patch(es) should be applied during awake hours and then left on continuously for approximately 18 hours or until usual bedtime sleep.
|
|
Placebo Comparator: Placebo patch
Participants will be instructed to apply a patch or patches (up to 3 maximum simultaneously) directly to the affected area.
The patch(es) should be applied during awake hours and then left on continuously for approximately 18 hours or until usual bedtime sleep.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain intensity rating (NRS)
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain as assessed by the Brief Pain Inventory-Short Form, Neuropathy Pain Scale, Subject Global Impression of Change, Pain Catastrophizing Scale, Profile of Mood States Short Form, and NCCTG Quality of Life
Time Frame: 8 weeks
|
8 weeks
|
Incidence of each toxicity reported in each treatment period
Time Frame: 8 weeks
|
8 weeks
|
Maximum severity reported of each toxicity
Time Frame: 8 weeks
|
8 weeks
|
Distribution of the overall toxicity score
Time Frame: 8 weeks
|
8 weeks
|
Proportion of patients who report a preference for lidocaine patch or placebo at study completion
Time Frame: 8 weeks
|
8 weeks
|
Proportion of patients who terminate treatment prematurely
Time Frame: up to 8 weeks
|
up to 8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Charles Loprinzi, MD, Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- NCCTG-N01CB
- CDR0000288824 (Registry Identifier: NCI Physician Reference Desk)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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