Phase 2
Completed N=84
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Source: ClinicalTrials.gov NCT01053962 ↗
Enrolled (actual)
84
Serious AEs
1.3%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants With Adverse Events — 3; 6; 2; 6 Participants
Summary
This is a Phase 2a, 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
3; 6; 2; 6; 4 | — |
| SECONDARY Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM) |
1.7; 3.3; 1.8; 2.7; 2.0 | — |
| SECONDARY Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM) |
2.4; 4.1; 2.4; 4.2; 2.4 | — |
| SECONDARY Changes From Baseline Overall in Bristol Stool Form Scale (BSFS) |
1.1; 1.8; 1.6; 1.8; 0.9 | — |
| SECONDARY Changes From Baseline Overall in Ease of Passage (Straining) |
0.9; 1.6; 1.3; 1.2; 0.5 | — |
Eligibility 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.
- Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.
Exclusion Criteria
- Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) 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.
- Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
Data sourced from ClinicalTrials.gov (NCT01053962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.