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A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00374881
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : April 15, 2008
Information provided by:
BioLineRx, Ltd.

Brief Summary:
Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low dose morphine analgesia.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Morphine Drug: Sorbitol+Phenylephrine Drug: Sorbitol+Phenylephrine+Morphine Drug: Sorbitol low concentration+Phenylephrine+Morphine Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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.
Study Start Date : September 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : August 2007

Arm Intervention/treatment
Active Comparator: 1
Morphine High Dose
Drug: Morphine

Placebo Comparator: 2
Morphine Low Dose
Drug: Morphine
Morphine low dose

Placebo Comparator: 3
Sorbitol Phenylephrine
Drug: Sorbitol+Phenylephrine

Experimental: 4
Sorbitol high concentration+Phenylephrine+Morphine
Drug: Sorbitol+Phenylephrine+Morphine

Experimental: 5
Sorbitol low concentration+Phenylephrine+Morphine
Drug: Sorbitol low concentration+Phenylephrine+Morphine
Sorbitol low concentration+Phenylephrine+Morphine

Primary Outcome Measures :
  1. Safety [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 4 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ability to provide written informed consent
  • Healthy male or female between 18 and 40 years of age, inclusive.
  • Women have to test negative for pregnancy.
  • Body weight within 15% of ideal body weight based on Metropolitan Life assurance tables.
  • No concomitant medications (prescription, OTC, vitamins, dietary supplements) within 7 days prior to administration of study medication and during the study period.
  • Ability to adhere to the visit schedule and protocol requirements and be available to complete the study
  • Ability to participate successfully in training sessions that will be arranged for the volunteers prior to the study day, during which they will acquire consistency in the tests to be performed.
  • Ability to satisfy a medical examiner about fitness to participate in the study

Exclusion Criteria:

  • prior use of chronic opioids
  • mental illness prior or present
  • evidence of significant concomitant disease, including renal, hepatic, cardiovascular, pulmonary, endocrinological, hematopoietic, or gastrointestinal disease, a neoplasm or any other clinically significant medical disorder, which in the Investigator's judgment contraindicate administration of the study medications
  • known allergy to any of the drugs used in this study
  • history of drug or alcohol abuse
  • significant abnormalities in screening physical exam
  • administration of drugs that may potentially inhibit or induce liver cytochrome P450 activity within 3 weeks prior to Day 0
  • any acute medical situation (e.g. acute infection) within 48 hours of Day 0, which is considered of significance by the Principal Investigator
  • unusual diet
  • administration of experimental medications within the previous 12 weeks.
  • inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function)
  • subjects who, in the judgment of the investigators, are likely to be non-compliant or uncooperative or unwilling to sign a consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00374881

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Hadassah Hebrew University Medical Center, Department of Anesthesiology
Jerusalem, Israel, 91120
Hadassah En Kerem Medical Centre
Jerusalem, Israel
Sponsors and Collaborators
BioLineRx, Ltd.
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Principal Investigator: Yehuda Ginosar, Bsc, MBBS Department of Anesthesiology, Hadassah Hebrew University Medical Center
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Responsible Party: BioLineRx Identifier: NCT00374881    
Other Study ID Numbers: BL-3010
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Acute Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Cardiotonic Agents
Autonomic Agents
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Gastrointestinal Agents