The Effect of Marketing Variable on Effect of Active Drugs

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01493908
First received: December 15, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

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 Intervention
Pain
Drug: High price
Drug: Low price
Drug: Low price participants aware paying part
Drug: No price
Drug: Free of charge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Price and Marketing Variable on the Pain Controlling Effect of Active Drugs in a Clinical Trial.

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • pain thresholds [ Time Frame: 1hour ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 220
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493908

Contacts
Contact: Amnon - Lahad, MD, MPH +972-2-6758505 ext - amnonl@cc.huji.ac.il
Contact: Hadas - Lemberg, PhD 00 972 2 6777572 ext - lhadas@hadassah.org.il

Locations
Israel
Department of Family Medicine, Hebrew University, JerusaelmIsrael Not yet recruiting
Jerusalem, Israel, 91120
Contact: Amnon - Lahad, MD, MPH    +972-2-758505 ext -    amnonl@cc.huji.ac.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Lahad - Amnon, MD, MPH         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Amnon - Lahad, MD, MPH Hebrew University, Jerusalem Israel
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01493908     History of Changes
Other Study ID Numbers: 1727-HMO-CTIL
Study First Received: December 15, 2011
Last Updated: December 15, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on October 20, 2014