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

NCT00374881 | Completed Phase 1

• 1 other identifier: BL-3010
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Safety

  8 hours

Secondary Outcomes (1)

• Efficacy

  4 hours

Study Arms (5)

1

ACTIVE COMPARATOR

Morphine High Dose

Drug: Morphine

2

PLACEBO COMPARATOR

Morphine Low Dose

Drug: Morphine

3

PLACEBO COMPARATOR

Sorbitol Phenylephrine

Drug: Sorbitol+Phenylephrine

4

EXPERIMENTAL

Sorbitol high concentration+Phenylephrine+Morphine

Drug: Sorbitol+Phenylephrine+Morphine

5

EXPERIMENTAL

Sorbitol low concentration+Phenylephrine+Morphine

Drug: Sorbitol low concentration+Phenylephrine+Morphine

Interventions

Morphine DRUG

Morphine

1

Sorbitol+Phenylephrine DRUG

Sorbitol+Phenylephrine

3

Sorbitol+Phenylephrine+Morphine DRUG

Sorbitol+Phenylephrine+Morphine

4

Sorbitol low concentration+Phenylephrine+Morphine DRUG

Sorbitol low concentration+Phenylephrine+Morphine

5

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioLineRx, Ltd.: lead

Study Sites (2)

Hadassah Hebrew University Medical Center, Department of Anesthesiology

Jerusalem, 91120, Israel

Location

Hadassah En Kerem Medical Centre

Jerusalem, Israel

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Yehuda Ginosar, Bsc, MBBS

  Department of Anesthesiology, Hadassah Hebrew University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 12, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: August 1, 2007
• Last Updated: April 15, 2008

Record last verified: 2008-04

Locations

IL (2)