NCT01036035

Brief Summary

THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

December 16, 2009

Last Update Submit

December 28, 2015

Conditions

Incontinence

Keywords

TolterodineOver active Bladder (OAB)Incontinence

Outcome Measures

Primary Outcomes (1)

  • Reductions in stimulated salivary flow (SSF)

    From Baseline

Secondary Outcomes (1)

  • Determine the pharmacokinetics of tolterodine and the agonist.

    From Baseline

Study Arms (5)

Treatment B

ACTIVE COMPARATOR

Study drug

Drug: Pilocarpine

Treatment D

ACTIVE COMPARATOR

Study drug

Drug: THVD-201

Treatment E

PLACEBO COMPARATOR

Placebo

Drug: placebo capsule

Treatment A

ACTIVE COMPARATOR

Study Drug

Drug: Tolterodine

Treatment C

ACTIVE COMPARATOR

Study Drug

Drug: THVD-201

Interventions

TolterodineDRUG

Comparison of different dosages of drug

Treatment A
PilocarpineDRUG

Comparison of different dosages of drug

Treatment B
THVD-201DRUG

Comparison of different dosages of drug

Treatment C
placebo capsuleDRUG

Comparison of different dosages of drug

Treatment E

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males, 18 - 45 years of age.
  • BMI 20-30 m2.

You may not qualify if:

  • Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives.
  • Clinically significant ECG, vital signs and clinical laboratory indices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tolterodine TartratePilocarpine

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenolsAlkaloidsHeterocyclic Compounds

Study Officials

  • Joanne Marjason

    Queensland Institute for Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 21, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

December 30, 2015

Record last verified: 2015-12