Clinical trial NCT00374881: A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Pain
Lead sponsor: BioLineRx, Ltd.
Sponsor class: INDUSTRY
First posted: 2006-09-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Safety
timeFrame: 8 hours
Secondary outcomes:
measure: Efficacy
timeFrame: 4 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center, Department of Anesthesiology
city: Jerusalem
country: Israel
facility: Hadassah En Kerem Medical Centre
Study officials:
affiliation: Department of Anesthesiology, Hadassah Hebrew University Medical Center
name: Yehuda Ginosar, Bsc, MBBS
role: PRINCIPAL_INVESTIGATOR
References: