CompletedInterventionalPhase 1Updated Dec 13, 2006
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women | NCT00620854 | Trialant
CompletedInterventionalPhase 2Updated Feb 1, 2012
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
ClinicalTrials.gov ID
NCT00620854
Lead Sponsor
Tarsa Therapeutics, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
24Actual
Last Update Posted
Feb 1, 2012Estimated
Start Date
Feb 2008
Primary Completion Date
Apr 2008Actual
Completion Date
Apr 2008Actual
Brief Summary
This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).
Osteoporosis
Recombinant Salmon Calcitonin (rsCT)
Oral Tablet
Nasal Spray
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Postmenopausal female, in good health (at least 5 years since last menses)
Age ≥45 and ≤70
Weight + or - 20% of the Metropolitan Life weight table
Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL
Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range
Willing and able to comply with all study requirements
Willing and able to sign written informed consent
Negative urine pregnancy test at screening
Negative Screen for Hepatitis B and C, human immunodeficiency virus (HIV) and drugs of abuse
Exclusion Criteria:
History of parathyroid, thyroid, pituitary or adrenal diseases
History of musculoskeletal disease
History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders
History of cancer within 5 years of enrollment other than basal cell carcinoma
History of regular use of non-steroidal anti-inflammatory drugs (NSAID)
History of surgery within 60 days of enrollment
History of hypersensitivity or allergies (other than seasonal allergies) within 5 years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications
Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study
Use of bisphosphonates within 6 months, selective selective estrogen receptor modulators (SERMS), estrogen or estrogen-like drugs 2 months, or calcitonin 1 month
Presence of any clinically significant illness
Unwilling or unable to comply with all study requirements
Unwilling or unable to sign written, informed consent
History of drug or alcohol abuse
Participation in any clinical study of an investigational drug within 60 days of enrollment