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

Primary Purpose

Acute Pain

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Morphine

Sorbitol+Phenylephrine

Sorbitol+Phenylephrine+Morphine

Sorbitol low concentration+Phenylephrine+Morphine

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hadassah Hebrew University Medical Center, Department of Anesthesiology
Hadassah En Kerem Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Arm Description

Morphine High Dose

Morphine Low Dose

Sorbitol Phenylephrine

Sorbitol high concentration+Phenylephrine+Morphine

Sorbitol low concentration+Phenylephrine+Morphine

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Efficacy

Full Information

NCT ID

NCT00374881

First Posted

September 11, 2006

Last Updated

April 14, 2008

Sponsor

BioLineRx, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00374881

Brief Title

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

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

BioLineRx, Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Morphine High Dose

Arm Title

Arm Type

Placebo Comparator

Arm Description

Morphine Low Dose

Arm Title

Arm Type

Placebo Comparator

Arm Description

Sorbitol Phenylephrine

Arm Title

Arm Type

Experimental

Arm Description

Sorbitol high concentration+Phenylephrine+Morphine

Arm Title

Arm Type

Experimental

Arm Description

Sorbitol low concentration+Phenylephrine+Morphine

Intervention Type

Drug

Intervention Name(s)

Morphine

Intervention Description

Morphine

Intervention Type

Drug

Intervention Name(s)

Morphine

Intervention Description

Morphine low dose

Intervention Type

Drug

Intervention Name(s)

Sorbitol+Phenylephrine

Intervention Description

Sorbitol+Phenylephrine

Intervention Type

Drug

Intervention Name(s)

Sorbitol+Phenylephrine+Morphine

Intervention Description

Sorbitol+Phenylephrine+Morphine

Intervention Type

Drug

Intervention Name(s)

Sorbitol low concentration+Phenylephrine+Morphine

Intervention Description

Sorbitol low concentration+Phenylephrine+Morphine

Primary Outcome Measure Information:

Title

Safety

Time Frame

8 hours

Secondary Outcome Measure Information:

Title

Efficacy

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yehuda Ginosar, Bsc, MBBS

Organizational Affiliation

Department of Anesthesiology, Hadassah Hebrew University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Hebrew University Medical Center, Department of Anesthesiology

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Hadassah En Kerem Medical Centre

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

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

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