Intranasal Civamide for Episodic Cluster Headache

This study has been completed.

Sponsor:

Information provided by:

Winston Laboratories

ClinicalTrials.gov Identifier:

NCT00069082

First received: September 15, 2003

Last updated: June 8, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 15, 2003

Last Updated Date

June 8, 2011

Start Date ^ICMJE

August 2003

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00069082 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intranasal Civamide for Episodic Cluster Headache

Official Title ^ICMJE

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache

Brief Summary

This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Episodic Cluster Headache

Intervention ^ICMJE

Drug: Civamide (Zucapsaicin)
Nasal Solution 0.01%
Drug: Sodium Chloride
Nasal Solution 10%

Study Arm (s)

Active Comparator: Civamide
Nasal Solution 0.01%

Intervention: Drug: Civamide (Zucapsaicin)
Placebo Comparator: Placebo
Placebo nasal solution with sodium chloride 10%

Intervention: Drug: Sodium Chloride

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2004

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

At least 2 year history of episodic cluster headache (meeting IHS criteria)
At least 2 previous episodes
Expected duration of cluster period is at least 6 weeks but not longer than 24 weeks
At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00069082

Other Study ID Numbers ^ICMJE

WL-1001-02-05

Has Data Monitoring Committee

Not Provided

Responsible Party

Scott B. Phillips, M.D., Study Director, Winston Laboratories, Inc.

Study Sponsor ^ICMJE

Winston Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Scott B Phillips, MD

Winston Laboratories

Information Provided By

Winston Laboratories

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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