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| Sponsor: | BioLineRx, Ltd. |
|---|---|
| Information provided by: | BioLineRx, Ltd. |
| ClinicalTrials.gov Identifier: | NCT00374881 |
Purpose
Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low dose morphine analgesia.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Pain |
Drug: Morphine Drug: Sorbitol+Phenylephrine Drug: Sorbitol+Phenylephrine+Morphine Drug: Sorbitol low concentration+Phenylephrine+Morphine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Single-Center, 5 Way Cross-Over Study to Assess the Effect of Adding Oral Phenylephrine and Oral Sorbitol to Low Dose (1.5 mg) Plain Oral Morphine in Human Volunteers: Analgesia and Side Effect Assessment. |
| Enrollment: | 9 |
| Study Start Date: | September 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Morphine High Dose
|
Drug: Morphine
Morphine
|
|
2: Placebo Comparator
Morphine Low Dose
|
Drug: Morphine
Morphine low dose
|
|
3: Placebo Comparator
Sorbitol Phenylephrine
|
Drug: Sorbitol+Phenylephrine
Sorbitol+Phenylephrine
|
|
4: Experimental
Sorbitol high concentration+Phenylephrine+Morphine
|
Drug: Sorbitol+Phenylephrine+Morphine
Sorbitol+Phenylephrine+Morphine
|
|
5: Experimental
Sorbitol low concentration+Phenylephrine+Morphine
|
Drug: Sorbitol low concentration+Phenylephrine+Morphine
Sorbitol low concentration+Phenylephrine+Morphine
|
The primary objective of this study is to determine the efficacy of the combined oral adjuvants phenylephrine and sorbitol on oral low dose morphine analgesia.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Israel | |
| Hadassah Hebrew University Medical Center, Department of Anesthesiology | |
| Jerusalem, Israel, 91120 | |
| Hadassah En Kerem Medical Centre | |
| Jerusalem, Israel | |
| Principal Investigator: | Yehuda Ginosar, Bsc, MBBS | Department of Anesthesiology, Hadassah Hebrew University Medical Center |
More Information
| Responsible Party: | BioLineRx ( BioLineRx ) |
| Study ID Numbers: | BL-3010 |
| Study First Received: | September 11, 2006 |
| Last Updated: | April 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00374881 History of Changes |
| Health Authority: | Israel: Ministry of Health |
|
Respiratory System Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Cathartics Adrenergic Agonists Nasal Decongestants Sensory System Agents Phenylephrine Therapeutic Uses Vasoconstrictor Agents Analgesics Analgesics, Opioid |
Morphine Adrenergic alpha-Agonists Sympathomimetics Gastrointestinal Agents Central Nervous System Depressants Sorbitol Narcotics Cardiovascular Agents Protective Agents Pharmacologic Actions Oxymetazoline Mydriatics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |