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

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Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Pain

Treatments: Drug: Sorbitol+Phenylephrine; Drug: Sorbitol low concentration+Phenylephrine+Morphine; Drug: Sorbitol+Phenylephrine+Morphine; Drug: Morphine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00374881

BL-3010

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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9 participants in 5 patient groups, including a placebo group

1

Active Comparator group

Description:

Morphine High Dose

Treatment:

Drug: Morphine

Drug: Morphine

2

Placebo Comparator group

Description:

Morphine Low Dose

Treatment:

Drug: Morphine

Drug: Morphine

3

Placebo Comparator group

Description:

Sorbitol Phenylephrine

Treatment:

Drug: Sorbitol+Phenylephrine

4

Experimental group

Description:

Sorbitol high concentration+Phenylephrine+Morphine

Treatment:

Drug: Sorbitol+Phenylephrine+Morphine

5

Experimental group

Description:

Sorbitol low concentration+Phenylephrine+Morphine

Treatment:

Drug: Sorbitol low concentration+Phenylephrine+Morphine