Submission date
12/08/2003
Registration date
11/09/2003
Last edited
20/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Retrospectively registered
? Protocol not yet added
? SAP not yet added
? Results not yet added and study completed for more than 2 years
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Ms Marisa Carmen

ORCID ID

Contact details

Novartis Pharmaceuticals
One Health Plaza
East Hanover
07936
United States of America

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

CHTF919A2306

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration.

Ethics approval(s)

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study type

Not Specified

Patient information sheet

Condition

Irritable bowel syndrome (IBS) with constipation

Intervention

Not provided at time of registration.

Intervention type

Other

Primary outcome measure

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall study start date

01/04/2002

Overall study end date

30/04/2003

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Females, 18 to 65 years, with IBS-C (Irritable Bowel Syndrome with constipation)

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Female

Target number of participants

THIS STUDY HAS COMPLETED PATIENT ENROLMENT

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/04/2002

Recruitment end date

30/04/2003

Locations

Countries of recruitment

United States of America

Study participating centre

Novartis Pharmaceuticals
East Hanover
07936
United States of America

Sponsor information

Organisation

Novartis Pharmaceuticals Corporation

Sponsor details

One Health Plaza
East Hanover
07936
United States of America

Sponsor type

Not defined

Website

ROR

https://ror.org/028fhxy95

Funders

Funder type

Industry

Funder name

Sponsored by Novartis Pharmaceuticals Corporation (http://click.atdmt.com/GTO/go/thbmbnov00700895gto/direct/01/)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes