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Intranasal Civamide for Episodic Cluster Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00069082
Recruitment Status : Completed
First Posted : September 16, 2003
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Winston Laboratories

Tracking Information
First Submitted Date  ICMJE September 15, 2003
First Posted Date  ICMJE September 16, 2003
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE August 2003
Actual 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: June 8, 2011)
2
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
30
Actual Study Completion Date  ICMJE January 2004
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00069082
Other Study ID Numbers  ICMJE WL-1001-02-05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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
PRS Account Winston Laboratories
Verification Date June 2011

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