A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP733 in Patients With Irritable Bowel Syndrome With Constipation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00215566

Enrollment

Registered

2005-09-22

Start date

2005-09-30

Completion date

Unknown

Last updated

2007-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome, Irritable Bowel Syndrome With Constipation

Keywords

IBS, IBS-c

Brief summary

This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.

Interventions

DRUGDDP733

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria * Must have had endoscopic/radiologic bowel evaluation within the past 10 years * Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers * Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding

Exclusion criteria

* Serious underlying diseases, including psychiatric disorders * Current history of conditions affecting bowel transit * Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection * Clinically significant abnormal examination findings or laboratory tests * Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments * Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome * Presence of a medical condition which could interfere with the interpretation of study data * Significant use of nicotine or caffeine

Design outcomes

Primary

Measure	Time frame
Evaluation of the effect of DDP733 on gastrointestinal transit	—

Secondary

Measure	Time frame
Evaluation of the effect of DDP733 on patient reported outcomes	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026