SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation (CIC)
This study has been completed.
Sponsor:
Synergy Pharmaceuticals, Inc.
Information provided by:
Synergy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01053962
First received: January 12, 2010
Last updated: November 16, 2010
Last verified: November 2010
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Purpose
This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Idiopathic Constipation |
Drug: SP-304 Drug: Placebo Drug: SP-304 0.3 mg |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase IIa Randomized, Double-Blind, Placebo-Controlled, 14-Day Repeat, Oral, Dose Ranging Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Effects of SP-304 in Patients With Chronic Idiopathic Constipation |
Resource links provided by NLM:
Further study details as provided by Synergy Pharmaceuticals, Inc.:
Primary Outcome Measures:
- To evaluate the safety of SP-304 (1.0 mg, 3.0 mg, 9.0 mg and 0.3 mg) for 14 days in patients with CIC [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess changes in bowel habits over time CSBM, SBM, Stool Consistency, Ease of Passage and Completeness of Evacuation in once daily oral dosing of SP-304 (1.0 mg, 3.0 mg, 9.0 mg and 0.3 mg) vs. placebo for 14 days in patients with CIC [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2010 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SP-304 1.0 mg
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
Drug: SP-304
Subjects receiving SP-304 1.0 mg for 14 consecutive days
|
|
Experimental: SP-304 3.0 mg
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
Drug: SP-304
Subjects receiving SP-304 3.0 mg for 14 consecutive days
|
|
Experimental: SP-304 9.0 mg
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
Drug: SP-304
Subjects receiving SP-304 9.0 mg for 14 consecutive days
|
|
Placebo Comparator: Placebo
Subjects receiving Placebo for 14 consecutive days
|
Drug: Placebo
Subjects receiving Placebo for 14 consecutive days
|
|
Experimental: SP-304 0.3 mg
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
|
Drug: SP-304 0.3 mg
Subjects receiving SP-304 0.3 mg for 14 consecutive
|
Detailed Description:
This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, PK and PD effects of SP-304 in patients with chronic idiopathic constipation. Subjects diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to yield 80 randomized subjects for enrollment. Three dose cohorts are planned (1.0 mg, 3.0mg, 9.0 mg and 0.3 mg) with 20 subjects per dose cohort [randomization ratio 3:1 (15 receive SP-304:5 receive placebo)]. Subjects who continue to meet all the entry criteria and complete the pre-treatment bowel movement (BM) diary will receive, in a double-blind, randomized fashion, SP-304 or matching placebo. It is expected that each subject will complete all 14 days of dosing (including making accurate BM diary entries for all 14 days in the treatment period). All subjects receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints. If a subject receives at least 5 doses per treatment week (1 dose per day for 7 days) and has completed BM diary entries for those 5 dosing days in each corresponding treatment week, he/she will be considered evaluable.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).
- Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
- Subject has a body mass index (BMI) between 18 and 35 kg/m2 (See Appendix A for formula to calculate BMI).
- Subject meets the Rome III Diagnostic Criteria for functional chronic idiopathic constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.
Exclusion Criteria:
- Subject reports loose stool (mushy) or watery stool (BSFS score of 6 or 7) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
- Subjects who meet the Rome III criteria for IBS: reports abdominal pain or discomfort > 3 days/week in the last 3 months with symptoms onset at > 6 months prior to diagnosis. a2 in the 14-day pre-treatment bowel movement diary.
- Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053962
Locations
| United States, Arizona | |
| Novara Clinical Research | |
| Mesa, Arizona, United States, 85206 | |
| Genova Clinical Research | |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| Advanced Clinical Research | |
| Anaheim, California, United States, 92801 | |
| Advanced Clinical Research | |
| Orange, California, United States, 92869 | |
| United States, Florida | |
| A.G.A. Clinical Trials | |
| Hialeah, Florida, United States, 33012 | |
| Miami Ressearch and Associates | |
| Miami, Florida, United States, 33143 | |
| United States, Kansas | |
| Lee Research Institute | |
| Shawnee, Kansas, United States, 66218 | |
| United States, Michigan | |
| Clinical Research Institute of Michigan, LLC | |
| Chesterfield, Michigan, United States, 48047 | |
| United States, North Carolina | |
| Universtiy of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Tennessee | |
| Memphis Gastroenterology Group | |
| Germantown, Tennessee, United States, 38138 | |
| Nashville Medical Research Institute | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| DCOL Center for Clinical Research | |
| Longview, Texas, United States, 75605 | |
| Pioneer Research Solutions | |
| Sugarland, Texas, United States, 77479 | |
Sponsors and Collaborators
Synergy Pharmaceuticals, Inc.
Investigators
| Study Director: | Gary S Jacob, Ph.D. | Synergy Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Craig C. Talluto, Ph.D., Synergy Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01053962 History of Changes |
| Other Study ID Numbers: | SP-SP304201-09 |
| Study First Received: | January 12, 2010 |
| Last Updated: | November 16, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Synergy Pharmaceuticals, Inc.:
|
Chronic Idiopathic Constipation Constipation Irritable Bowel Syndrome |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013