PainNCT01493908
The Effect of Marketing Variable on Effect of Active Drugs
A study testing High price, Low price and Low price participants aware paying part in people with Pain, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The efficacy of the placebo effect has been proved in many prior studies by comparing the symptoms and measures of patients. Placebo has been proved to help in treating illnesses such as depression, stomach ulcer and chronic headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- High price, Low price and Low price participants aware paying part
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Jun 2013
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteer participants will be between the ages of 18 and 65
Who cannot join
- Candidates who have had a history of cardiac problems, epilepsy, diabetes, or are pregnant will be excluded.
- Taking no pain medication at the time of the experiment.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Family Medicine, Hebrew University, JerusaelmIsrael
Jerusalem, 91120
Amnon - Lahad, MD, MPH, +972-2-758505, amnonl@cc.huji.ac.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: The Effect of Price and Marketing Variable on the Pain Controlling Effect of Active Drugs in a Clinical Trial.
The efficacy of the placebo effect has been proved in many prior studies by comparing the symptoms and measures of patients. Placebo has been proved to help in treating illnesses such as depression, stomach ulcer and chronic headaches.
A Meta analysis checked 47 studies about placebo and showed great significance when a patient is treated with placebo pill, no active substance, just by activating conditioning and expectation mechanism in his body, thus providing to the healing process, and that is it's importance.
Read more
In recent years studies established a relationship between marketing variables (such as price, label) to the efficacy of a product. In addition- a unique research run in 2008 showed a significant relationship between the marketing strategies and the efficacy of medication; more specifically, patients in this research experienced less (controlled) pain when treated with placebo medication introduced to them as more expensive than patients treated with placebo medication that was introduced to them as much cheaper. All patients were treated with the exact same medication.
In the investigator's experiment the investigators design a laboratory experiment to determine if marketing factors could invoke the placebo effects described earlier. For the initial laboratory experiment, we decided to examine the difference in price, on the efficacy of an OTC analgesic through the mediation of low- voltage electrical pulses to the patient's wrist.
The investigators study hypothesis is that marketing variables such as price and brand name will affect the therapeutic efficacy of an analgesic, i.e. a medicine will have greater influence when the patient is aware of its price compared to one who is not.
- Conditions
- Pain
- Being tested
- High price, Low price, Low price participants aware paying part, No price, Free of charge
- Keywords
- Placebo effect;, Pain; Analgesic;, Electrical shock, control in healthy volunteers
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High priceDrug
Acetaminophen label as high price
Low priceDrug
Acetaminophen label as low price
Low price participants aware paying partDrug
Acetaminophen label as low price; participants aware they are paying part of the full price
No priceDrug
acetaminophen. No price - price issue not introduced to participants.
Free of chargeDrug
Acetaminophen. participants aware the product is free of charge
| Study group | Role | What they receive |
|---|---|---|
| High price | Active comparator | Not described Receives: Drug: High price |
| Low price | Active comparator | Not described Receives: Drug: Low price |
| Low price participants aware paying part | Active comparator | Not described Receives: Drug: Low price participants aware paying part |
| No price | Active comparator | Not described Receives: Drug: No price |
| Free of charge | Active comparator | Not described Receives: Drug: Free of charge |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain thresholds
Participants will rank their pain thresholds individually and subjectively for a series of pulses. Each participant will experience a series of pulses with random intensity. Pulse intensity will range within 30-90% of the participants maximal level.
Measured: 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amnon - Lahad, MD, MPH, Principal investigator, Hebrew University, Jerusalem Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493908
- Sponsor's protocol ID
- 1727-HMO-CTIL
- Status last verified
- Dec 2011
- First submitted
- 15 Dec 2011
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Price and Marketing Variable on the Pain Controlling Effect of Active Drugs in a Clinical Trial.
- ClinicalTrials.gov ID
- NCT01493908
- Acronym / sponsor ID
- 1727-HMO-CTIL
- Conditions
- Pain
- Keywords
- Placebo effect;, Pain; Analgesic;, Electrical shock, control in healthy volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 16 Dec 2011 (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.
The efficacy of the placebo effect has been proved in many prior studies by comparing the symptoms and measures of patients. Placebo has been proved to help in treating illnesses such as depression, stomach ulcer and chronic headaches.
A Meta analysis checked 47 studies about placebo and showed great significance when a patient is treated with placebo pill, no active substance, just by activating conditioning and expectation mechanism in his body, thus providing to the healing process, and that is it's importance.
In recent years studies established a relationship between marketing variables (such as price, label) to the efficacy of a product. In addition- a unique research run in 2008 showed a significant relationship between the marketing strategies and the efficacy of medication; more specifically, patients in this research experienced less (controlled) pain when treated with placebo medication introduced to them as more expensive than patients treated with placebo medication that was introduced to them as much cheaper. All patients were treated with the exact same medication.
In the investigator's experiment the investigators design a laboratory experiment to determine if marketing factors could invoke the placebo effects described earlier. For the initial laboratory experiment, we decided to examine the difference in price, on the efficacy of an OTC analgesic through the mediation of low- voltage electrical pulses to the patient's wrist.
The investigators study hypothesis is that marketing variables such as price and brand name will affect the therapeutic efficacy of an analgesic, i.e. a medicine will have greater influence when the patient is aware of its price compared to one who is not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High price | Active comparator | Drug: High price |
| Low price | Active comparator | Drug: Low price |
| Low price participants aware paying part | Active comparator | Drug: Low price participants aware paying part |
| No price | Active comparator | Drug: No price |
| Free of charge | Active comparator | Drug: Free of charge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Volunteer participants will be between the ages of 18 and 65
Key exclusion criteria (2 listed)
- Candidates who have had a history of cardiac problems, epilepsy, diabetes, or are pregnant will be excluded.
- Taking no pain medication at the time of the experiment.
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 |
|---|---|---|
| High priceAcetaminophen label as high price | Drug | High price |
| Low priceAcetaminophen label as low price | Drug | Low price |
| Low price participants aware paying partAcetaminophen label as low price; participants aware they are paying part of the full price | Drug | Low price participants aware paying part |
| No priceacetaminophen. No price - price issue not introduced to participants. | Drug | No price |
| Free of chargeAcetaminophen. participants aware the product is free of charge | Drug | Free of charge |
Primary outcome
pain thresholds
Time frame: 1hour
Participants will rank their pain thresholds individually and subjectively for a series of pulses. Each participant will experience a series of pulses with random intensity. Pulse intensity will range within 30-90% of the participants maximal level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
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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.
Amnon - Lahad, MD, MPH principal investigator
Hebrew University, Jerusalem Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High price, Low price and Low price participants aware paying part in people with Pain, run by Hadassah Medical Organization at 1 site 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amnon - Lahad, MD, MPH (+972-2-6758505, amnonl@cc.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain thresholds (time frame: 1hour). 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 16 Dec 2011.