Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Completed · Phase 3

Conditions studied: Chronic Idiopathic Constipation

In brief

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)

Key facts

Study ID

NCT01895543

Run by

Ferring Pharmaceuticals

People needed

411

Starts

2013-09-01

Expected to finish

2015-05-01

Last updated by the study team

2016-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has completed double-blind treatment in either of the lead-in efficacy trials, 000079 or 000080.
• The patient reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all trial visits and assessments.
• The patient agrees to refrain from making any new, major lifestyle changes that may affect CIC symptoms (i.e., starting a new diet, changing an exercise plan) from the time of signing the ICF through to the last trial visit.

You may not qualify if…

• The patient has been withdrawn/discontinued from the 000079 or 000080 trials.
• The patient is not willing to abide by the restrictions for intake of prohibited medication.
• Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who have a positive urine pregnancy test at Visit 1, or who do not agree to use one of the following methods of birth control from the day of signing the ICF until 30 days after the final dose of trial drug are excluded:
• Transdermal patch
• Established use of oral, injected or implanted hormonal methods of contraception
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
• Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
• True sexual abstinence: when this is in line with the preferred and usual lifestyle of the patient.
• The patients is considered by the Investigator to be unsuitable to participate in the trial for any other reason.

Where it is running

• Preferred Research Partners — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Skyline Research, LLC — Cerritos, California, United States
• West Gastroenterology Associates — Los Angeles, California, United States
• Sacramento Research Medical Group — Sacramento, California, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Zasa Clinical Research — Boynton Beach, Florida, United States
• Meridien Research — Bradenton, Florida, United States
• Pulmonary Associates of Brandon — Brandon, Florida, United States
• Health Care Family Rehab Corp. — Hialeah, Florida, United States
• Medsearch Professional Group, Inc. — Hialeah, Florida, United States
• The Community Research of South Florida — Hialeah, Florida, United States
• Center for Gastrointestinal Disorders — Hollywood, Florida, United States
• Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Jupiter Research Inc. — Jupiter, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Research Institute of South Florida — Miami, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Mount Vernon Clinical Research — Atlanta, Georgia, United States
• Georgia Clinical Research — Snellville, Georgia, United States
• Evanston Hospital — Evanston, Illinois, United States
• Rockford Gastroenterology Associates, Ltd. — Rockford, Illinois, United States
• MediSphere Medical Research Center, LLC — Evansville, Indiana, United States
• Genova Clinical Research, Inc. — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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