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

NCT01021176 | Terminated Phase 1

• 1 other identifier: PBRC 27016
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Intake

Keywords

Food Intake; Hunger; Lidocaine; Nose; smell

Outcome Measures

Primary Outcomes (1)

• Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray.

  3 weeks

Study Arms (4)

0mg 0 spray

PLACEBO COMPARATOR

No Diltiazem

Other: Placebo spray

2mg 2 Spray

ACTIVE COMPARATOR

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

Drug: Diltiazem

4mg 4 Spray

ACTIVE COMPARATOR

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

Drug: Diltiazem

8mg 8 spray

ACTIVE COMPARATOR

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

Drug: Diltiazem

Interventions

Placebo spray OTHER

0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray yet no drug will be administered

Also known as: Placebo

0mg 0 spray

Diltiazem DRUG

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.

Also known as: 5.5, 6.0, 6.3 and/or one more randomly

2mg 2 Spray; 4mg 4 Spray; 8mg 8 spray

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Compellis Pharmaceuticals: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Anosmia

Interventions

Diltiazem

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Frank L. Greenway, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 26, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

US (1)