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

Acute Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374881
• Other study ID #: BL-3010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 11, 2006
• Last updated: April 14, 2008
• Start date: September 2006
• Est. completion date: August 2007

Study information

• Verified date: April 2008
• Source: BioLineRx, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Morphine
Morphine
• Morphine
Morphine low dose
• Sorbitol+Phenylephrine
Sorbitol+Phenylephrine
• Sorbitol+Phenylephrine+Morphine
Sorbitol+Phenylephrine+Morphine
• Sorbitol low concentration+Phenylephrine+Morphine
Sorbitol low concentration+Phenylephrine+Morphine

Locations

Country	Name	City	State
Israel	Hadassah En Kerem Medical Centre	Jerusalem
Israel	Hadassah Hebrew University Medical Center, Department of Anesthesiology	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
BioLineRx, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		8 hours	Yes
Secondary	Efficacy		4 hours	No