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Last Updated: December 9, 2019

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CLINICAL TRIALS PROFILE FOR ACETAMINOPHEN

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505(b)(2) Clinical Trials for ACETAMINOPHEN

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
OTC NCT00245375 A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC NCT00245375 A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed Nova Scotia Health Authority N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC NCT00267293 Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Children Youth and Family Consortium Phase 4 2006-01-01 Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
OTC NCT00267293 Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Penn State University Phase 4 2006-01-01 Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
New Combination NCT00378547 Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy Terminated Glostrup University Hospital, Copenhagen Phase 4 2006-01-01 Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.
New Formulation NCT01118663 Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection Terminated Cumberland Pharmaceuticals Phase 3 2010-09-01 The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.
OTC NCT01188096 A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas Recruiting Emory University Phase 2 2010-08-01 This study is for patients up to 21 years of age who have a tumor called a low grade glioma of the central nervous system (brain and spinal cord). The tumor has grown despite attempts to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that tend to grow slowly and could be cured if every bit of the tumor were surgically removed. These tumors are called Grade I or II astrocytomas. These tumors often grow in parts of the brain that prevent total removal without devastating neurologic complications or death. Although some low grade gliomas never grow, most will and are treated with either chemotherapy or radiation. There is good data showing that the growth of most low grade gliomas can be controlled with chemotherapy or radiation. However, some low grade gliomas in children and young adults grow despite these treatments. Poly-ICLC is a new drug that has been used safely in children and adults with different types of brain tumors. Earlier studies showed that this drug worked better for children and young adults with low grade gliomas than for children with more aggressive brain tumors. The main purpose of this study is to use Poly-ICLC treatment in a larger number of patients to see how well it works and how many side effects occur. As Poly-ICLC is not FDA approved, this study is authorized to use it under IND# 43984, held by Oncovir. Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments will be given in the clinic so allergic or other severe reactions, if any, can be monitored. If subjects tolerate the injections and don't have a severe reaction, then the rest of the injections will be given at home. Subjects/caregivers will be trained to give injections. Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2 years if their tumor shrinks in response to the injections, if study doctors think it is safe, if subjects want to remain on treatment, and if Poly-ICLC is available. Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study, and at higher doses. Frequently seen side effects include irritation of the skin at the injection site and mild flu-like symptoms. These are usually relieved or avoided by use of over-the-counter medicines like acetaminophen (Tylenol). Funding Source: FDA OOPD
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for ACETAMINOPHEN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000425 Toward Better Outcomes in Osteoarthritis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 3 1996-07-01 This study will determine if there is a difference between commonly used nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (a pain-reliever that does not prevent inflammation) for treating knee pain in osteoarthritis (OA). The two main results we will look at are disease progression according to x-rays and disability over 3.5 years. Study participants with moderate knee OA and knee pain will continue taking their NSAID or stop taking their NSAID and start taking acetaminophen. Every 6 months we will send the participants questionnaires that ask about pain, medication use, and disability. We will take x-rays of the knees at the start of the study and again at the end of the study.
NCT00000425 Toward Better Outcomes in Osteoarthritis Completed Stanford University Phase 3 1996-07-01 This study will determine if there is a difference between commonly used nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (a pain-reliever that does not prevent inflammation) for treating knee pain in osteoarthritis (OA). The two main results we will look at are disease progression according to x-rays and disability over 3.5 years. Study participants with moderate knee OA and knee pain will continue taking their NSAID or stop taking their NSAID and start taking acetaminophen. Every 6 months we will send the participants questionnaires that ask about pain, medication use, and disability. We will take x-rays of the knees at the start of the study and again at the end of the study.
NCT00000491 Aspirin-Myocardial Infarction Study (AMIS) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1974-10-01 To determine whether the daily administration of 1 gm of aspirin to individuals with a documented myocardial infarction would result in a significant reduction in mortality over a three year period.
NCT00000713 A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine the safety of ampligen at several doses in HIV-infected patients who have not yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and immunologic effects will be studied. Evidence indicates that a long period with no symptoms follows infection with HIV. Individuals who are infected with the virus could benefit from therapy with a drug that acts to kill the virus or to stimulate the immune system of the individual or both. The immune system is the means the human body has for fighting infections. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable clinical side effects.
NCT00000731 Evaluation of the Interaction Between Acetaminophen and Zidovudine Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To determine if zidovudine (AZT) and acetaminophen (APAP) interact when given to the same patient, and if so, the manner of interaction. Patients with AIDS often require therapy with painkillers for the management of mild pain and discomfort associated with their disease, and APAP is often prescribed. AZT is being used to treat AIDS patients. It is important for doctors to understand how AZT and APAP may interact when given to the same patient, because other studies have suggested that the dosage of AZT may have to be adjusted when given with APAP in order to avoid or minimize adverse effects.
NCT00000735 A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine the safety of intravenous infusion of ampligen in symptomatic HIV-infected patients at several dose levels, to determine the maximum dose that can be tolerated, and to measure the effects of ampligen on the HIV virus infection, immune function, and clinical condition. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit replication of HIV in vitro at doses that can be achieved without noticeable harmful side effects.
NCT00003346 Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma Completed National Cancer Institute (NCI) Phase 2 1997-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of acetaminophen plus carmustine in treating patients who have stage III or stage IV melanoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ACETAMINOPHEN

Condition Name

Condition Name for ACETAMINOPHEN
Intervention Trials
Pain 118
Pain, Postoperative 69
Postoperative Pain 48
Osteoarthritis 25
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Condition MeSH

Condition MeSH for ACETAMINOPHEN
Intervention Trials
Pain, Postoperative 168
Osteoarthritis 65
Acute Pain 38
Leukemia 34
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Clinical Trial Locations for ACETAMINOPHEN

Trials by Country

Trials by Country for ACETAMINOPHEN
Location Trials
Canada 88
United Kingdom 28
France 15
Brazil 14
Egypt 13
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Trials by US State

Trials by US State for ACETAMINOPHEN
Location Trials
Texas 143
New York 93
California 89
Pennsylvania 68
Ohio 64
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Clinical Trial Progress for ACETAMINOPHEN

Clinical Trial Phase

Clinical Trial Phase for ACETAMINOPHEN
Clinical Trial Phase Trials
Phase 4 312
Phase 3 160
Phase 2/Phase 3 22
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Clinical Trial Status

Clinical Trial Status for ACETAMINOPHEN
Clinical Trial Phase Trials
Completed 388
Recruiting 209
Not yet recruiting 175
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Clinical Trial Sponsors for ACETAMINOPHEN

Sponsor Name

Sponsor Name for ACETAMINOPHEN
Sponsor Trials
M.D. Anderson Cancer Center 48
Mallinckrodt 29
Montefiore Medical Center 15
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Sponsor Type

Sponsor Type for ACETAMINOPHEN
Sponsor Trials
Other 878
Industry 331
NIH 60
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