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

This study has been completed.
Sponsor:
Information provided by:
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT00374881
First received: September 11, 2006
Last updated: April 14, 2008
Last verified: April 2008
History of Changes
  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 1
Phase 2

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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BioLineRx, Ltd.:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374881

Locations
Israel
Hadassah Hebrew University Medical Center, Department of Anesthesiology
Jerusalem, Israel, 91120
Hadassah En Kerem Medical Centre
Jerusalem, Israel
Sponsors and Collaborators
BioLineRx, Ltd.
Investigators
Principal Investigator: Yehuda Ginosar, Bsc, MBBS Department of Anesthesiology, Hadassah Hebrew University Medical Center
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 21, 2013