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Last Updated: December 12, 2019

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CLINICAL TRIALS PROFILE FOR DIAZEPAM

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505(b)(2) Clinical Trials for Diazepam

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 NCT00244777 Introduction of Hypo-osmolar ORS for Routine Use Completed United States Agency for International Development (USAID) Phase 4 2002-12-01 The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation NCT00244777 Introduction of Hypo-osmolar ORS for Routine Use Completed International Centre for Diarrhoeal Disease Research, Bangladesh Phase 4 2002-12-01 The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Diazepam

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004297 Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus Completed University of California, San Francisco Phase 3 1995-11-01 OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus. II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission. III. Establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.
NCT00004297 Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 3 1995-11-01 OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus. II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission. III. Establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.
NCT00030004 Pilot Study of Spinal Manipulation for Chronic Neck Pain Terminated National Center for Complementary and Integrative Health (NCCIH) Phase 1 2000-05-01 This study is designed to determine whether a medicine that can produce temporary amnesia (midazolam) can be used to block the memory of treatment with spinal manipulation. This is important since any study that is designed to determine whether spinal manipulation is effective would be better if patients were not aware of whether or not they were treated. This would allow a true assessment of treatment effects without the complication of a strong placebo effect that manipulative treatment may produce.
NCT00106106 Acamprosate to Reduce Symptoms of Alcohol Withdrawal Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 2005-03-01 This study will examine whether a new drug called acamprosate can be helpful for alcohol withdrawal, a result of drinking high amounts of alcohol for long periods of time. Alcohol withdrawal can cause various symptoms, including nausea or vomiting, anxiety or depression, tremor, high blood pressure, and others. During withdrawal, brain chemicals called neurotransmitters change, with some rising to abnormally high levels. These changes may contribute to alcohol craving, drinking relapse and impaired mental performance. This study will see if taking acamprosate for 4 weeks can lower the levels of neurotransmitters, such as glutamate, lessen withdrawal symptoms and decrease alcohol craving and brain damage associated with withdrawal. Healthy normal volunteers and alcohol-dependent patients between 21 and 65 years of age may be eligible for this study. Participants are admitted to the hospital for 28 days. They receive standard inpatient care for alcohol detoxification, including a medical history and physical examination, neurological evaluation, laboratory tests, nursing, nutrition, discharge planning and referrals for treatment of concomitant conditions, if needed. In addition, they are randomly assigned to take either two acamprosate or two placebo pills three times a day for 28 days and undergo the following tests and procedures: - Days 1-28: Drug treatment. Patients take acamprosate or placebo daily. Patients with severe withdrawal symptoms may also receive diazepam (Valium). Throughout their hospitalization, patients fill out questionnaires about their emotional state and personality and are interviewed by staff about their mental health, use of alcohol, cigarettes, and illicit drugs, employment, support systems and family and social relationships, and their legal status. - Days 2 and 3: Blood tests. Blood is tested for levels of the stress hormones cortisol and ACTH, which are released to excess during alcohol withdrawal. For this test, a heparin lock (thin, flexible plastic tube with a rubber stopper on the end) is placed in an arm vein for blood collections each day at 6 AM, 12 noon, 6 PM and 12 midnight. Patients rest in bed for 30 minutes before each collection. - Day 4: Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). These procedures are done at the same time. They use a strong magnetic field and radio waves to show structural and chemical changes in the brain. The patient lies on a table in a space enclosed by a metal cylinder (the scanner) for about 20 to 30 minutes during the test. - Day 5: Lumbar puncture (spinal tap). A local anesthetic is given to numb the area for the procedure. Then, a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. - Days 5 and 6: Dexamethasone-corticotropin releasing factor (CRF) test. This test measures the effect of alcohol withdrawal on ACTH and cortisol. The patient takes a standard dose of the steroid dexamethasone at 11 PM on day 5. At noon the next day, they are given lunch and then stay in bed and rest. A plastic tube is put in an arm vein. A salt water solution is slowly infused through the catheter and a blood sample is withdrawn through it. At 3 p.m., the patient is given 100 micrograms of the hormone CRF. Repeated blood samples are obtained to measure ACTH and cortisol. - Days 23-27: All of the tests done on days 2-6 are repeated, except the MRI. MRS is repeated to measure neurotransmitters.
NCT00106106 Acamprosate to Reduce Symptoms of Alcohol Withdrawal Completed National Institutes of Health Clinical Center (CC) Phase 2 2005-03-01 This study will examine whether a new drug called acamprosate can be helpful for alcohol withdrawal, a result of drinking high amounts of alcohol for long periods of time. Alcohol withdrawal can cause various symptoms, including nausea or vomiting, anxiety or depression, tremor, high blood pressure, and others. During withdrawal, brain chemicals called neurotransmitters change, with some rising to abnormally high levels. These changes may contribute to alcohol craving, drinking relapse and impaired mental performance. This study will see if taking acamprosate for 4 weeks can lower the levels of neurotransmitters, such as glutamate, lessen withdrawal symptoms and decrease alcohol craving and brain damage associated with withdrawal. Healthy normal volunteers and alcohol-dependent patients between 21 and 65 years of age may be eligible for this study. Participants are admitted to the hospital for 28 days. They receive standard inpatient care for alcohol detoxification, including a medical history and physical examination, neurological evaluation, laboratory tests, nursing, nutrition, discharge planning and referrals for treatment of concomitant conditions, if needed. In addition, they are randomly assigned to take either two acamprosate or two placebo pills three times a day for 28 days and undergo the following tests and procedures: - Days 1-28: Drug treatment. Patients take acamprosate or placebo daily. Patients with severe withdrawal symptoms may also receive diazepam (Valium). Throughout their hospitalization, patients fill out questionnaires about their emotional state and personality and are interviewed by staff about their mental health, use of alcohol, cigarettes, and illicit drugs, employment, support systems and family and social relationships, and their legal status. - Days 2 and 3: Blood tests. Blood is tested for levels of the stress hormones cortisol and ACTH, which are released to excess during alcohol withdrawal. For this test, a heparin lock (thin, flexible plastic tube with a rubber stopper on the end) is placed in an arm vein for blood collections each day at 6 AM, 12 noon, 6 PM and 12 midnight. Patients rest in bed for 30 minutes before each collection. - Day 4: Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). These procedures are done at the same time. They use a strong magnetic field and radio waves to show structural and chemical changes in the brain. The patient lies on a table in a space enclosed by a metal cylinder (the scanner) for about 20 to 30 minutes during the test. - Day 5: Lumbar puncture (spinal tap). A local anesthetic is given to numb the area for the procedure. Then, a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. - Days 5 and 6: Dexamethasone-corticotropin releasing factor (CRF) test. This test measures the effect of alcohol withdrawal on ACTH and cortisol. The patient takes a standard dose of the steroid dexamethasone at 11 PM on day 5. At noon the next day, they are given lunch and then stay in bed and rest. A plastic tube is put in an arm vein. A salt water solution is slowly infused through the catheter and a blood sample is withdrawn through it. At 3 p.m., the patient is given 100 micrograms of the hormone CRF. Repeated blood samples are obtained to measure ACTH and cortisol. - Days 23-27: All of the tests done on days 2-6 are repeated, except the MRI. MRS is repeated to measure neurotransmitters.
NCT00121563 Evaluation of a TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect Completed National Institute of Nursing Research (NINR) Phase 2 2005-07-01 This study will evaluate the role of thalidomide, a tumor necrosis factor (TNF)-alpha modulator, on severe inflammation and relief of pain following extraction of wisdom teeth. TNFs are substances that affect the pathways of pain. This study involves an experimental group in which patients will be given thalidomide or a placebo (an inactive substance); a negative control group receiving the medication diazepam or a placebo; and a positive control group receiving diazepam or ibuprofen. Patients who are males ages 16 to 35, who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics, and who in good health may be eligible for this study. Females are not eligible, owing to the risks that thalidomide presents to unborn children. To minimize the risk of fetal malformations, male patients who participate must use a condom during sexual intercourse for 4 weeks following the study and must not donate blood for 4 weeks. The medications used in the study will be given 1 hour before surgery. Then after the wisdom teeth are removed, a small piece of tubing will be placed into both sides of the patient's mouth where the teeth were removed. Every 20 minutes, for the next 6 hours, the researchers will collect inflammatory fluid from the tubing, to measure for changes in anti-inflammatory action. If they request pain relievers, patients will receive the medication ketorolac (Toradol), used for short-term treatment of moderately severe acute pain. Side effects of thalidomide include fatigue, dizziness, and rash. The use of ibuprofen and ketorolac may include the risk of gastrointestinal ulcers and bleeding. Diazepam can cause involuntary muscle movements and drowsiness, as well as dizziness lasting for up to 24 hours after it has been used as sedation. Patients will be instructed not to try to walk alone or to try to drive a vehicle during that period. Other risks related to participation in this study include those usually experienced with removal of wisdom teeth-that is, pain and swelling, bruising from insertion of the sedative into a vein (if needed), possible infection at the extraction site, prolonged bleeding, and numbness. Benefits from participating are having wisdom teeth removed at no cost as well as close monitoring before and after surgery. Results from the study may help people in the future by improving the management of pain following surgery.
NCT00127257 Biofeedback for Dyssynergic Constipation Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A 1999-09-01 Constipation affects 4% of adults in the United States (U.S.). An estimated half of constipated patients are unable to relax pelvic floor muscles during defecation, a type of constipation called pelvic floor dyssynergia (PFD). Biofeedback has been recommended for the treatment of constipation because uncontrolled studies over the past 10 years suggest that these treatments are as effective as medical or surgical management and involve no risk. However, placebo-controlled trials are still lacking. The aims of this study are: - to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit; - to identify which patients are most likely to benefit; and - to assess the impact of treatment on quality of life.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Diazepam

Condition Name

Condition Name for Diazepam
Intervention Trials
Epilepsy 9
Pain 4
Alcohol Withdrawal 3
Anxiety 3
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Condition MeSH

Condition MeSH for Diazepam
Intervention Trials
Epilepsy 9
Status Epilepticus 7
Seizures 7
Pain, Postoperative 5
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Clinical Trial Locations for Diazepam

Trials by Country

Trials by Country for Diazepam
Location Trials
United States 135
France 5
Egypt 5
Canada 3
Germany 3
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Trials by US State

Trials by US State for Diazepam
Location Trials
New York 10
Pennsylvania 10
Texas 8
California 7
North Carolina 7
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Clinical Trial Progress for Diazepam

Clinical Trial Phase

Clinical Trial Phase for Diazepam
Clinical Trial Phase Trials
Phase 4 34
Phase 3 8
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Diazepam
Clinical Trial Phase Trials
Completed 54
Recruiting 20
Unknown status 8
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Clinical Trial Sponsors for Diazepam

Sponsor Name

Sponsor Name for Diazepam
Sponsor Trials
Acorda Therapeutics 4
Henry Ford Health System 4
B.P. Koirala Institute of Health Sciences 3
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Sponsor Type

Sponsor Type for Diazepam
Sponsor Trials
Other 99
Industry 21
NIH 9
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