NCT00374881

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

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: BioLineRx, Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Morphine	Morphine
DRUG	Morphine	Morphine low dose
DRUG	Sorbitol+Phenylephrine	Sorbitol+Phenylephrine
DRUG	Sorbitol+Phenylephrine+Morphine	Sorbitol+Phenylephrine+Morphine
DRUG	Sorbitol low concentration+Phenylephrine+Morphine	Sorbitol low concentration+Phenylephrine+Morphine

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-06-01
• Completion: 2007-08-01
• First posted: 2006-09-12
• Last updated: 2008-04-15

Locations

2 sites across 1 country: Israel