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Last Updated: May 29, 2020

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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.
>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 4
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Condition MeSH

Condition MeSH for Diazepam
Intervention Trials
Epilepsy 9
Seizures 8
Status Epilepticus 7
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Clinical Trial Locations for Diazepam

Trials by Country

Trials by Country for Diazepam
Location Trials
United States 136
Egypt 6
France 5
Australia 3
Canada 3
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Diazepam
Clinical Trial Phase Trials
Phase 4 36
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 22
Not yet recruiting 12
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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 112
Industry 21
NIH 9
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