Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder

NCT00746681 | Completed Phase 2

• 1 other identifier: A8881001
• Study Type: interventional
• Target: 188
• Locations: 6 countries
• Sites: 23

Brief Summary

Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Change in mean voided volume per micturition (from baseline).

  4 weeks

Secondary Outcomes (8)

• Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).

  4 Weeks

• Percentage and absolute change in urgency episode frequency

  4 Weeks

• Mean severity of urgency episodes

  4 Weeks

• Percentage and absolute change in micturition frequency

  4 Weeks

• Percentage and absolute change in normalized micturition frequency (NMF)

  4 Weeks

Study Arms (5)

A

EXPERIMENTAL

Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily

Drug: Tolterodine & Pregabalin

B

ACTIVE COMPARATOR

Tolterodine SR 4 mg once daily

Drug: Tolterodine

C

PLACEBO COMPARATOR

Placebo

Drug: Placebo

D

EXPERIMENTAL

Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily

Drug: Tolterodine & Pregabalin

E

EXPERIMENTAL

Pregabalin 150 mg twice daily

Drug: Pregabalin

Interventions

Tolterodine & Pregabalin DRUG

Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks

A

Tolterodine DRUG

Tolterodine SR, Oral, 4 mg, once daily for 4 weeks

B

Placebo DRUG

Placebo, Oral, twice daily for 4 weeks

C

Pregabalin DRUG

Pregabalin, Oral, 150 mg twice daily for 4 weeks

E

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \> 18 years Old
• Diagnosis of OAB (micturition frequency \>/= 8 times per day; urinary urgency \>/= 4 times per week)

You may not qualify if:

• Subjects with symptoms of overactive bladder for less than 6 months prior to randomization.
• Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
• Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (23)

Pfizer Investigational Site

Hradec Králové, 500 05, Czechia

Location

Pfizer Investigational Site

Prague, 110 00, Czechia

Location

Pfizer Investigational Site

Prague, 130 00, Czechia

Location

Pfizer Investigational Site

Praha 4 - Krc, 140 59, Czechia

Location

Pfizer Investigational Site

Ústí nad Labem, 401 13, Czechia

Location

Pfizer Investigational Site

Kaunas, LT-47144, Lithuania

Location

Pfizer Investigational Site

Kaunas, LT-50009, Lithuania

Location

Pfizer Investigational Site

Vilnius, LT-01118, Lithuania

Location

Pfizer Investigational Site

Vilnius, LT-08661, Lithuania

Location

Pfizer Investigational Site

Haugesund, 5507, Norway

Location

Pfizer Investigational Site

Moelv, N-2390, Norway

Location

Pfizer Investigational Site

Trondheim, 7006, Norway

Location

Pfizer Investigational Site

Martin, Slovakia, Slovakia

Location

Pfizer Investigational Site

Bratislava, 901 01, Slovakia

Location

Pfizer Investigational Site

Košice, 040 11, Slovakia

Location

Pfizer Investigational Site

Skalica, 909 82, Slovakia

Location

Pfizer Investigational Site

Luleå, 97180, Sweden

Location

Pfizer Investigational Site

Norrköping, 601 82, Sweden

Location

Pfizer Investigational Site

Stockholm, 141 86, Sweden

Location

Pfizer Investigational Site

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Pfizer Investigational Site

Bristol, BS10 5NB, United Kingdom

Location

Pfizer Investigational Site

Dundee, DD1 9SY, United Kingdom

Location

Pfizer Investigational Site

Plymouth, PL6 8DH, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate; Pregabalin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: September 4, 2008
• Study Start: December 1, 2005
• Study Completion: November 1, 2006
• Last Updated: December 21, 2009

Record last verified: 2009-12

Locations

GB (4); SL (4); LI (4); CZ (5); SE (3); NO (3)