The Effect of Marketing Variable on Effect of Active Drugs

Pain Clinical Trial

Official title:

The Effect of Price and Marketing Variable on the Pain Controlling Effect of Active Drugs in a Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01493908
• Other study ID #: 1727-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 15, 2011
• Last updated: December 15, 2011
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2011
• Source: Hadassah Medical Organization
• Contact: Amnon - Lahad, MD, MPH
• Phone: +972-2-6758505
• Email: amnonl[@]cc.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• High price
Acetaminophen label as high price
• Low price
Acetaminophen label as low price
• Low price participants aware paying part
Acetaminophen label as low price; participants aware they are paying part of the full price
• No price
acetaminophen. No price - price issue not introduced to participants.
• Free of charge
Acetaminophen. participants aware the product is free of charge

Locations

Country	Name	City	State
Israel	Department of Family Medicine, Hebrew University, JerusaelmIsrael	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No