The Effect of Marketing Variable on Effect of Active Drugs

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.

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 Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Drug: High price; Drug: Low price; Drug: Low price participants aware paying part; Drug: No price; Drug: Free of charge

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Department of Family Medicine, Hebrew University, JerusaelmIsrael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1hour

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Amnon - Lahad, MD, MPH, Hebrew University, Jerusalem Israel

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Estimate): December 16, 2011
• Last Update Submitted That Met QC Criteria: December 15, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Placebo effect;; Pain; Analgesic;; Electrical shock; control in healthy volunteers
• Other Study ID Numbers: 1727-HMO-CTIL