Acute PainPhase 1/2NCT00374881
A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects
A Phase 1/2 study testing Morphine, Sorbitol+Phenylephrine and Sorbitol+Phenylephrine+Morphine in people with Acute Pain, run by BioLineRx, Ltd. at 2 sites in Israel.
Trial summary
Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low dose morphine analgesia. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Morphine, Sorbitol+Phenylephrine and Sorbitol+Phenylephrine+Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2006to Aug 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Hebrew University Medical Center, Department of Anesthesiology
Jerusalem, 91120
Hadassah En Kerem Medical Centre
Jerusalem
About this study
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.
Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low dose morphine analgesia.
Read the 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
- Being tested
- Morphine, Sorbitol+Phenylephrine, Sorbitol+Phenylephrine+Morphine, Sorbitol low concentration+Phenylephrine+Morphine
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Morphine
MorphineDrug
Morphine low dose
Sorbitol+PhenylephrineDrug
Sorbitol+Phenylephrine
Sorbitol+Phenylephrine+MorphineDrug
Sorbitol+Phenylephrine+Morphine
Sorbitol low concentration+Phenylephrine+MorphineDrug
Sorbitol low concentration+Phenylephrine+Morphine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Morphine High Dose Receives: Drug: Morphine |
| 2 | Placebo comparator | Morphine Low Dose Receives: Drug: Morphine |
| 3 | Placebo comparator | Sorbitol Phenylephrine Receives: Drug: Sorbitol+Phenylephrine |
| 4 | Experimental | Sorbitol high concentration+Phenylephrine+Morphine Receives: Drug: Sorbitol+Phenylephrine+Morphine |
| 5 | Experimental | Sorbitol low concentration+Phenylephrine+Morphine Receives: Drug: Sorbitol low concentration+Phenylephrine+Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 8 hours
Secondary outcomes (1)
Efficacy
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioLineRx, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yehuda Ginosar, Bsc, MBBS, Principal investigator, Department of Anesthesiology, Hadassah Hebrew University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374881
- Sponsor's protocol ID
- BL-3010
- Status last verified
- Apr 2008
- First submitted
- 11 Sep 2006
- Last updated
- 15 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00374881
- Acronym / sponsor ID
- BL-3010
- Conditions
- Acute Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- BioLineRx, Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MorphineMorphine High Dose |
| 2 | Placebo comparator | Drug: MorphineMorphine Low Dose |
| 3 | Placebo comparator | Drug: Sorbitol+PhenylephrineSorbitol Phenylephrine |
| 4 | Experimental | Drug: Sorbitol+Phenylephrine+MorphineSorbitol high concentration+Phenylephrine+Morphine |
| 5 | Experimental | Drug: Sorbitol low concentration+Phenylephrine+MorphineSorbitol low concentration+Phenylephrine+Morphine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineMorphine | Drug | 1 |
| MorphineMorphine low dose | Drug | 2 |
| Sorbitol+PhenylephrineSorbitol+Phenylephrine | Drug | 3 |
| Sorbitol+Phenylephrine+MorphineSorbitol+Phenylephrine+Morphine | Drug | 4 |
| Sorbitol low concentration+Phenylephrine+MorphineSorbitol low concentration+Phenylephrine+Morphine | Drug | 5 |
Primary outcome
Safety
Time frame: 8 hours
1 secondary outcome
Efficacy
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehuda Ginosar, Bsc, MBBS principal investigator
Department of Anesthesiology, Hadassah Hebrew University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Morphine, Sorbitol+Phenylephrine and Sorbitol+Phenylephrine+Morphine in people with Acute Pain, run by BioLineRx, Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2008.