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SMS995

Phase 1

Irritable Bowel Syndrome (IBS) | Small molecule | Gastrointestinal |Novartis AG|Last Updated: May 8, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

SMS995 · 1 trial · 1 indication

Phase 1 1
NCT00584298Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using OctreotideIrritable Bowel Syndrome (IBS)
COMPLETED50 Analytics
PHASE1COMPLETED
Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide
Irritable Bowel Syndrome (IBS)Unlock trial analytics

Study Endpoints

Primary Endpoints

- 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol.
throughout the study

Secondary Endpoints

- colorectal compliance
throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SMS995DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * A positive diagnosis of IBS. * Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local * contraception. * Able to communicate well with the investigator, to understand and ...

Countries:United StatesCanadaSwedenUnited Kingdom
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Competitive Landscape -Irritable Bowel Syndrome 12 trials (matched to "Irritable Bowel Syndrome (IBS)")

Frequently asked questions about SMS995

What is SMS995 used for?

SMS995 is an investigational small molecule being developed for Irritable Bowel Syndrome (IBS), a gastrointestinal condition. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes SMS995?

SMS995 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 1 clinical trials for Irritable Bowel Syndrome.

What phase is SMS995 in?

SMS995 is in Phase 1 clinical development. It is an investigational drug for Irritable Bowel Syndrome and has not been approved by the FDA or other regulatory agencies. One Phase 1 trial has been completed.

What clinical trials is SMS995 in?

SMS995 has one completed Phase 1 clinical trial, registered under NCT00584298. The trial, titled 'Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide,' enrolled 50 female participants with Irritable Bowel Syndrome across the United States, Canada, Sweden, and the United Kingdom.

Is SMS995 the same as octreotide?

No, SMS995 is not the same as octreotide. The completed Phase 1 trial NCT00584298 used octreotide as a pharmacological modulator to assess colorectal sensation, but SMS995 is the investigational drug being developed for Irritable Bowel Syndrome. The trial was designed to evaluate the feasibility of barostat assessments.