Trial | NCT00374881  Report issue

Title

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.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    phenylephrine sorbitol morphine ...

  • Study Participants

    9
Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low dose morphine analgesia.
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.
Study Started
Sep 30
2006
Primary Completion
Jun 30
2007
Study Completion
Aug 31
2007
Last Update
Apr 15
2008
Estimate

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

1 Active Comparator

Morphine High Dose

2 Placebo Comparator

Morphine Low Dose

3 Placebo Comparator

Sorbitol Phenylephrine

4 Experimental

Sorbitol high concentration+Phenylephrine+Morphine

5 Experimental

Sorbitol low concentration+Phenylephrine+Morphine

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
No Results Posted