Evaluate a Medication on How Hunger and Appetite Are Influenced by Smell

• ClinicalTrials.gov Identifier: NCT01021176
• Recruitment Status: Terminated
• First Posted: November 26, 2009
• Last Update Posted: December 18, 2015
• Sponsor: Pennington Biomedical Research Center
• Collaborator: Compellis Pharmaceuticals
• Information provided by (Responsible Party): Frank Greenway, Pennington Biomedical Research Center

Tracking Information

• First Submitted Date: November 24, 2009
• First Posted Date: November 26, 2009
• Last Update Posted Date: December 18, 2015
• Study Start Date: October 2009
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 25, 2009): Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray. [ Time Frame: 3 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluate a Medication on How Hunger and Appetite Are Influenced by Smell
• Official Title: A Single Dose Pilot Study to Evaluate the Safety and Dose-Response of Smell to Intranasal Diltiazem
• Brief Summary: The purpose of this study is to determine whether the blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray which will then reduce food intake.
• Detailed Description: You will fast on your first visit. Complete questionnaire about taste and smell to insure you don't have a cold or anything that would interfere with sense of smell. Your nose will be checked. Blood pressure taken, and administer to you a spray with diltiazem 2, 4, 8 mg or a placebo. Your sense of smell will be tested at different time points.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Food Intake

Intervention

• Other: Placebo spray
  0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray yet no drug will be administered
  Other Name: Placebo
• Drug: Diltiazem
  0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray Three Dilutions would be 5.5, 6.0 and 6.3 and the fourth at the filp of a coin randomly diluted.
  Other Name: 5.5, 6.0, 6.3 and/or one more randomly

Study Arms

• Placebo Comparator: 0mg 0 spray
  No Diltiazem
  Intervention: Other: Placebo spray
• Active Comparator: 2mg 2 Spray
  Staff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 2mg/2 spray Diltiazem
  Intervention: Drug: Diltiazem
• Active Comparator: 4mg 4 Spray
  Staff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 4mg/4 spray Diltiazem
  Intervention: Drug: Diltiazem
• Active Comparator: 8mg 8 spray
  Staff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 8mg/8 spray Diltiazem
  Intervention: Drug: Diltiazem

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 21, 2012): 12
• Original Actual Enrollment (submitted: November 25, 2009): 120
• Actual Study Completion Date: November 2009
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Body mass index (BMI) between 25 and 40 kg
• Blood pressure in within normal range

Exclusion Criteria:

• Used tobacco products in the past month
• Used a calcium channel blocker medication in the last month
• used nasal sprays in the last month
• have an abnormal sense of smell or abnormalities of the lining in your nose
• female and have irregular menstrual periods
• female and are nursing a baby or pregnant
• female and have had a partial hysterectomy (still have ovaries)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01021176
• Other Study ID Numbers: PBRC 27016
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Frank Greenway, Pennington Biomedical Research Center
• Original Responsible Party: Frank L. Greenway, MD, Pennington Biomedical Research Center
• Current Study Sponsor: Pennington Biomedical Research Center
• Original Study Sponsor: Same as current
• Collaborators: Compellis Pharmaceuticals

Investigators

• Principal Investigator: Frank L. Greenway, MD; Pennington Biomedical Research Center

• PRS Account: Pennington Biomedical Research Center
• Verification Date: December 2015