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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Active Comparator: 1
Morphine High Dose
|
Drug: Morphine
Morphine
|
|
Placebo Comparator: 2
Morphine Low Dose
|
Drug: Morphine
Morphine low dose
|
|
Placebo Comparator: 3
Sorbitol Phenylephrine
|
Drug: Sorbitol+Phenylephrine
Sorbitol+Phenylephrine
|
|
Experimental: 4
Sorbitol high concentration+Phenylephrine+Morphine
|
Drug: Sorbitol+Phenylephrine+Morphine
Sorbitol+Phenylephrine+Morphine
|
|
Experimental: 5
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 |
| ClinicalTrials.gov Identifier: | NCT00374881 History of Changes |
| Other Study ID Numbers: | BL-3010 |
| Study First Received: | September 11, 2006 |
| Last Updated: | April 14, 2008 |
| Health Authority: | Israel: Ministry of Health |
|
Morphine Phenylephrine Oxymetazoline Sorbitol Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics Adrenergic alpha-1 Receptor Agonists |
Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Cardiovascular Agents Mydriatics Autonomic Agents Sympathomimetics Vasoconstrictor Agents Nasal Decongestants Respiratory System Agents Protective Agents Cathartics |