CLINICAL TRIALS PROFILE FOR TRAMADOL HYDROCHLORIDE

505(b)(2) Clinical Trials for TRAMADOL HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00640159 ↗	Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease	Completed	Baylor College of Medicine	Phase 4	2007-01-01	Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.
OTC	NCT01588158 ↗	Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery	Terminated	Massachusetts General Hospital	Phase 4	2012-07-01	Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of this emphasis on opioid pain medication is driven by the pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry. There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission led to an increased incidence of prescription of opioids, but there is less evidence of improved satisfaction with pain relief. There is some evidence of an increase in opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the Emergency Department for opioid overdose doubled between 2004 and 2008. Patients in other countries take far less opioid pain medication and are equally satisfied with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and have comparable or better satisfaction with pain relief than American patients, most of whom take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine use after a femur fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological differences are striking and suggest strongly that personal factors may be the most important determinant of satisfaction with pain relief. It is our impression that most American hand surgeons give patients a prescription for an opioid pain medication after carpal tunnel release, and that is certainly true in our practice. This seems to be based primarily on the outliers, and intended to avoid confrontation with patients that desire opioids; however, most patients take little or no narcotic pain medication, and many who do use the opioids complain of the side effects-nausea and pruritis in particular. It is therefore not clear whether routine opioids is the optimal pain management strategy after carpal tunnel release. In the study of Stahl et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen or other pain medication at all after the operation. Our aim is to determine if there is a difference in satisfaction with pain relief between patients advised to take opioids compared to patients advised to use over the counter acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to determine if personal factors account for more of the variability in satisfaction with pain relief than opioid strategy.
New Formulation	NCT03766984 ↗	Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac	Completed	Grünenthal Colombiana S.A.	Phase 1	2015-06-07	The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
New Formulation	NCT03766984 ↗	Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac	Completed	Grünenthal S.A.	Phase 1	2015-06-07	The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
New Formulation	NCT03766984 ↗	Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac	Completed	Grünenthal GmbH	Phase 1	2015-06-07	The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
OTC	NCT04694300 ↗	OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients	Recruiting	Bayer	Phase 4	2021-02-07	This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.

All Clinical Trials for TRAMADOL HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00058357 ↗	Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery	Completed	National Cancer Institute (NCI)	Phase 3	2004-05-01	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.
NCT00058357 ↗	Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2004-05-01	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.
NCT00111046 ↗	Pain Relief - Tramadol Versus Ibuprofen	Unknown status	Royal Liverpool University Hospital	Phase 1/Phase 2	2001-02-01	The purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol.
NCT00115752 ↗	Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain	Completed	National Institute of Nursing Research (NINR)	Phase 2	2005-06-20	This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in genes may explain why an analgesic drug, that is, one that treats pain, works effectively for some people but not for others. The study will explore pain that is acute (fast and short period). Knowledge gained from this ongoing study may permit development of an individualized analgesic drug prescription. Patients ages 16 to 35 who are in good health and have been referred for removal of impacted wisdom teeth; who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics; who are not pregnant or nursing; and who are willing to have a biopsy before and after dental surgery are eligible for this study. Patients will come to the clinic for one test visit and one treatment visit. During the first visit, a questionnaire will evaluate patients' psychological state, including mood and depression. There will be a clinical examination of their wisdom teeth. A blood sample of 10 milliliters (about 0.4 ounces) will be collected from the forearm to provide DNA material containing genes stored in cells. The primary genetic analysis will be done at NIH, although the DNA collected might also be sent to a laboratory outside NIH. DNA samples will be coded so that names of patients cannot be traced. During the second visit, two of the patients' lower wisdom teeth will be removed. Patients will be given a local anesthetic in the mouth and a sedative given through a vein in the arm. While the mouth is numb, a small piece of tissue will be removed from inside the cheek, near the wisdom tooth. It is the first biopsy. After the two wisdom teeth are removed, a small piece of tubing will be placed into both sides of the mouth where the teeth were removed. Every 20 minutes, for the next 3 hours, the researchers will collect inflammatory fluid from the tubing, to measure the chemicals thought to cause pain and swelling. Also every 20 minutes, patients will rate the pain they feel by answering questions. If there is pain before 3 hours following surgery, they will receive a dose of fentanyl to relieve moderate to severe pain. A second biopsy will occur 3 hours after surgery, to measure changes in chemicals produced in response to surgery. Immediately afterward, patients will receive 30 mg of ketorolac (Toradol) whether or not pain is felt. They will answer questionnaires about pain for 3 hours after receiving the drug, to rate how well it works. They will stay at the clinic up to 6 hours after the surgery. If pain is not relieved with ketorolac, patients will receive a one-time dose of tramadol, a pain medication for moderate to severe pain. After the study procedures are completed, patients will receive pain medication for pain after surgery. Patients will be monitored closely, because all drugs have side effects. Ketorolac is a nonsteroidal anti-inflammatory drug, one that may cause gastrointestinal upset. Fentanyl is a powerful narcotic drug that is safe at the dosage used in this study, but stomach upset, dizziness, and breathing trouble may occur. Also, risks from the biopsy include discomfort from injecting the numbing medicine, infection, and bleeding. There may be discomfort from the sedative injected into the vein, and there may be bruising. Benefits from participating are having wisdom teeth removed at no cost as well as close monitoring before and after surgery. There are no plans to give patients the results of genetic tests or questionnaires. Years of research may be needed before such information has the chance to become meaningful.
NCT00142896 ↗	Tramadol to Reduce Opioid Withdrawal Symptoms	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2005-02-01	Individuals with opioid addiction often experience serious withdrawal symptoms that may make relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by chronic conditions such as cancer or joint pain, may also be effective at reducing opioid withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing withdrawal symptoms in individuals addicted to opioid drugs.
NCT00163553 ↗	Neuraxial Pethidine After Lumbar Surgery Trial	Unknown status	Austin Health	Phase 3	2004-12-01	The hypothesis is that epidural pethidine is an effective form of pain relief following lumbar spinal surgery, resulting in significantly lower usage of concomitantly administered (intravenous) patient-controlled analgesia (PCA) pethidine.

Clinical Trial Conditions for TRAMADOL HYDROCHLORIDE

Condition Name

Condition Name for TRAMADOL HYDROCHLORIDE
Intervention	Trials
Pain	60
Postoperative Pain	46
Pain, Postoperative	32
Healthy	20

Condition MeSH

Condition MeSH for TRAMADOL HYDROCHLORIDE
Intervention	Trials
Pain, Postoperative	97
Osteoarthritis	31
Acute Pain	21
Chronic Pain	20

Clinical Trial Locations for TRAMADOL HYDROCHLORIDE

Trials by Country

Trials by Country for TRAMADOL HYDROCHLORIDE
Location	Trials
United States	147
Turkey	47
Egypt	36
Brazil	20
Italy	17

Trials by US State

Trials by US State for TRAMADOL HYDROCHLORIDE
Location	Trials
Maryland	12
Texas	11
California	9
New York	8
Pennsylvania	8

Clinical Trial Progress for TRAMADOL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for TRAMADOL HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	184
Phase 3	75
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for TRAMADOL HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	277
Unknown status	58
Recruiting	57

Clinical Trial Sponsors for TRAMADOL HYDROCHLORIDE

Sponsor Name

Sponsor Name for TRAMADOL HYDROCHLORIDE
Sponsor	Trials
Labopharm Inc.	15
Cairo University	13
Janssen Korea, Ltd., Korea	10

Sponsor Type

Sponsor Type for TRAMADOL HYDROCHLORIDE
Sponsor	Trials
Other	450
Industry	140
U.S. Fed	17