A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects
Information source: BioLineRx, Ltd.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Pain
Intervention: Morphine (Drug); Morphine (Drug); Sorbitol+Phenylephrine (Drug); Sorbitol+Phenylephrine+Morphine (Drug); Sorbitol low concentration+Phenylephrine+Morphine (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: BioLineRx, Ltd. Official(s) and/or principal investigator(s):
Yehuda Ginosar, Bsc, MBBS, Principal Investigator, Affiliation: Department of Anesthesiology, Hadassah Hebrew University Medical Center
Summary
Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low
dose morphine analgesia.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Safety
Secondary outcome: Efficacy
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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
Hadassah Hebrew University Medical Center, Department of Anesthesiology, Jerusalem 91120, Israel
Hadassah En Kerem Medical Centre, Jerusalem, Israel
Additional Information
Starting date: September 2006
Ending date: August 2007
Last updated: April 14, 2008
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