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The Effect of Marketing Variable on Effect of Active Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493908
Recruitment Status : Unknown
Verified December 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : December 16, 2011
Last Update Posted : December 16, 2011
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Pain Drug: High price Drug: Low price Drug: Low price participants aware paying part Drug: No price Drug: Free of charge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Price and Marketing Variable on the Pain Controlling Effect of Active Drugs in a Clinical Trial.
Study Start Date : January 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2013

Arm Intervention/treatment
Active Comparator: High price Drug: High price
Acetaminophen label as high price

Active Comparator: Low price Drug: Low price
Acetaminophen label as low price

Active Comparator: Low price participants aware paying part Drug: Low price participants aware paying part
Acetaminophen label as low price; participants aware they are paying part of the full price

Active Comparator: No price Drug: No price
acetaminophen. No price - price issue not introduced to participants.

Active Comparator: Free of charge Drug: Free of charge
Acetaminophen. participants aware the product is free of charge

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy Volunteer participants will be between the ages of 18 and 65

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01493908

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Contact: Amnon - Lahad, MD, MPH +972-2-6758505
Contact: Hadas - Lemberg, PhD 00 972 2 6777572

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Department of Family Medicine, Hebrew University, JerusaelmIsrael Not yet recruiting
Jerusalem, Israel, 91120
Contact: Amnon - Lahad, MD, MPH    +972-2-758505   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Lahad - Amnon, MD, MPH         
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Amnon - Lahad, MD, MPH Hebrew University, Jerusalem Israel

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Responsible Party: Hadassah Medical Organization Identifier: NCT01493908     History of Changes
Other Study ID Numbers: 1727-HMO-CTIL
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011

Keywords provided by Hadassah Medical Organization:
Placebo effect;
Pain; Analgesic;
Electrical shock
control in healthy volunteers