Assessing Tolerability of Avonex Intramuscular Injections

Multiple Sclerosis Clinical Trial

Official title:

Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641120
• Other study ID #: 11-12-002
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: December 18, 2015
• Start date: May 2012
• Est. completion date: February 2014

Study information

• Verified date: December 2015
• Source: Saint Francis Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Between 18 - 65 years of age;

• Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis;

• Currently being treated with Avonex® for at least 90 days;

• Using 25 gauge needles for injection of Avonex® for at least 90 days;

• Willing and able to complete study questionnaires; and

• Provided informed consent to participate in this study

Exclusion Criteria:

• Diagnosis of Progressive Multiple Sclerosis;

• History of recent illness or infection;

• History of allergic reaction to Avonex®;

• Any prior usage of a 30 gauge needle for administration of Avonex®;

• Concurrent treatment with other immunomodulating therapies;

• Pregnant or planning on becoming pregnant;

• Nursing mothers; and

• Unable to complete the requirements of the study

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Avonex
Intramuscular injection administered using 25 gauge or 30 gauge needle

Locations

Country	Name	City	State
United States	The Mandell Center for Multiple Sclerosis	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Saint Francis Care	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Visual Analog Scale Score for Pre-injection Anxiety	The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety.; Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.; Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.	Weeks 2, 3, 4, 5	No
Primary	Visual Analog Scale Score for Post-injection Pain	The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain.; Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.; Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.	Weeks 2, 3, 4, 5	No
Secondary	Fear of Injection	Secondary endpoint was assessment of fear of injection based on patient questionnaires completed prior to each injection. The patient will respond to each statement on a scale which ranges from 1 (almost always) to 4 (almost never).; Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes fear of injection for the 30 gauge needle.; Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes fear of injection for the 25 gauge needle.	Weeks 2, 3, 4, 5	No
Secondary	Perception of Needle	Secondary endpoint was assessment of the perception of the needle based on patient questionnaires completed after each injection. The patient will respond to each statement on a scale which ranges from 1 (strongly agree) to 5 (strongly disagree).; A total of 6 statements were given to the participant the more strongly the participant agreed with the statement, the more favorably they perceived the needle.; Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes perception of the 30 gauge needle.; Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes perception of the 25 gauge needle.	Weeks 2, 3, 4, 5	No