DeLand, FL (PRWEB) November 19, 2013
*To see if you qualify for this Constipation Clinical Trial in Florida, visit Avail Clinical Research on the web (http://www.availclinical.com) or contact us directly at (386) 785-2404. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
STUDY DESIGN
This is a phase 3, multi-center study evaluating the pharmacodynamics and tolerability of a new liquid form drug that is administered orally to patients with chronic idiopathic constipation. Additionally, liquid formulation PK, including a comparison of fed and fasted PK, of the liquid formulation will be performed for a subset of subjects. Approximately 152 participants will be randomized to study treatment in a 1:1 ratio to receive either the new liquid constipation drug or matching placebo during confinement (Day 1 through Day 7) before they check out on the morning of Day 8.
A subset of subjects (approximately 30) will remain confined for an additional 2 days after the main study confinement period, during which time fasted PK sampling following a single open-label dose of liquid study medication will be collected on Day 9. The liquid preparation will be added to a soft food vehicle such as yogurt or pudding for administration. Participants will receive standardized meals throughout the confinement period.
DURATION OF STUDY PARTICIPATION
Enrollment at approximately 11 sites within the United States is anticipated. Duration of study participation is up to 7 weeks from the beginning of the screening period until the follow-up visit.
BACKGROUND & RATIONALE
A liquid formulation for this constipation drug has been developed for oral administration. This product consists of the same contents present in the capsule form, plus the addition of vanilla flavor and neotame as corrigents. The formulation is filled in quantitative push-pump dispenser bottles which will discharge 12 mcg of the constipation drug per stroke.
The availability of this new liquid form constipation drug provides an alternate dosing formulation for subjects who prefer not to take capsule forms (there are few good approved drugs for constipation). The purpose of this study is to compare the pharmacodynamics of this constipation drug to a placebo, and to access pharmacokinetics (PK) of the liquid formulation in the fed and fasted state. The dose selected for this study is equivalent to that of the FDA approved dosage for the capsule form used to treat chronic idiopathic constipation in adults.
PRIMARY OBJECTIVES
Evaluate the pharmacodynamics and tolerability of a liquid formulation of this new liquid formulation, as compared to a matching placebo, when administered orally in subjects with chronic idiopathic constipation. Additionally, liquid formulation PK, including comparison of fed and fasted PK, of the liquid formulation will be performed in a subset of subjects.
INCLUSION CRITERIA
Subjects must satisfy the following criteria before entering the study:
-Subject is male or female, 18 - 65 years of age
-If female, subject not pregnant, non-lactating, and either postmenopausal for at least 1 --year, surgically sterile for at least 3 months (i.e. surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation), is abstinent, or, if engaged in heterosexual conduct, is willing to use 2 of the following forms of contraception from 10 days prior to Check in until 30 days post follow-up:
-A non-hormonal contraceptive medication
-non-hormonal intrauterine device with spermicide;
-female condom with spermicide;
-diaphragm with spermicide;
-cervical cap with spermicide;
-condom with spermicide by male sexual partner; or
-sterile male sexual partner.
Subject agrees not to use hormone replacement therapy within 35 days prior to Check-in until 30 days after Follow-up. For females of childbearing potential, the pregnancy test must be negative at Screening and Check-in.
Subject either has medically-confirmed diagnosis of chronic constipation, or meets the diagnosis as confirmed using the Rome Ill constipation module questionnaire during the Screening period.
Subject is able to comprehend and willing to sign an lCD approved by the IRB after explanation of the nature and objectives of the study and prior to the conduct of any study specific procedure.
If subject is taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility, he/she must discontinue use from no later than Day -15 of the
Screening period through the confinement period; these medications include:
Anticholinergics (except ipratropium bromide or any inhaled or nasal-spray forms of this medication);
Anti-spasmodics;
Cholinesterase inhibitors;
Anti-diarrheal medications;
Anti-constipation medications;
Prokinetic agents;
Laxative agents, including homeopathic remedies;
Tricyclic antidepressants; and
Any medications at the discretion of the Investigator known to relieve or cause constipation or constipation symptoms.
Subject is willing to discontinue use of laxative and stool softeners from no later than Day -15 of the Screening period through the confinement period (use of approved rescue laxatives will be allowed under certain protocol-specified circumstances).
If subject is taking a fiber supplement, usage must have been at a stable dose and schedule for at least 30 days prior to the Screening Visit and not likely to change during the study.
For subjects participating in PK sampling, subject is able, and willing, to ingest dairy products (e.g., is not lactose intolerant) and does not have other dietary restrictions that would preclude them from ingesting the pre-dose meal (i.e., high-fat breakfast) on Day 1.
Subject daily diary indicates an average of less than 3 spontaneous bowel movements (SBMs) during the week prior to Check-in for the confinement period (Days -8 to -2).
Subject has at least one of the following for at least 25% of SBMs during the week prior to
Check-in (as reported in the daily diary from Day -8 to -2)
Bristol Stool Scale Type 1, 2, or 3; and/or
Moderate to very severe straining associated with SBMs
If subject has ever taken this constipation drug, he/she must be actively prescribed and taking 24 meg at the time of screening and for at least 30 days prior to the Screening visit; subject must also be willing to discontinue taking this medication for at least 28 days prior to Check-in and for the duration of the study (through the Follow-up visit).
*We are also now enrolling for this Irritable Bowel Syndrome (IBS) Clinical Trial in Florida.
- Avail Clinical Research conducts a variety of Clinical Trials in Florida. For more information about participating in a Constipation Clinical Study, please visit our website or contact us directly at (386) 785-2404.
