Trial record 1 of 1 for:
NCT01569438
The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01569438 |
Recruitment Status :
Terminated
First Posted : April 3, 2012
Results First Posted : January 12, 2017
Last Update Posted : August 17, 2020
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Sponsor:
Afferent Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Bladder Pain Syndrome |
Interventions |
Drug: Gefapixant Drug: Placebo |
Enrollment | 107 |
Participant Flow
Recruitment Details | Overall, 107 participants were randomized (55 in Gefapixant intervention group, and 52 in Placebo group). |
Pre-assignment Details | Of 107 participants randomized to the study, 105 received at least one dose of study treatment (All Treated Population) and were evaluable for all safety analysis. |
Arm/Group Title | Placebo | Gefapixant |
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Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks. | Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred. |
Period Title: Overall Study | ||
Started | 52 | 55 |
Treated | 51 | 54 |
Titration Set | 38 | 36 |
Completed | 45 | 33 |
Not Completed | 7 | 22 |
Reason Not Completed | ||
Lack of Efficacy | 1 | 2 |
Withdrawal by Subject | 0 | 3 |
Adverse Event | 2 | 15 |
Protocol Violation | 2 | 0 |
Decrease of GFR greater than 30 ml/min | 1 | 0 |
Sponsor/Physician decision | 1 | 1 |
Unable to adhere to study schedule | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Gefapixant | Placebo | Total | |
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Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred. | Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 55 | 52 | 107 | |
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All randomized participants
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 55 participants | 52 participants | 107 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
50 90.9%
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52 100.0%
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102 95.3%
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>=65 years |
5 9.1%
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0 0.0%
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5 4.7%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 55 participants | 52 participants | 107 participants | |
Female |
55 100.0%
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52 100.0%
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107 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 55 participants | 52 participants | 107 participants | |
Hispanic or Latino |
3 5.5%
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0 0.0%
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3 2.8%
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Not Hispanic or Latino |
52 94.5%
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52 100.0%
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104 97.2%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 55 participants | 52 participants | 107 participants | |
American Indian or Alaska Native |
2 3.6%
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0 0.0%
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2 1.9%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
5 9.1%
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6 11.5%
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11 10.3%
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White |
46 83.6%
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46 88.5%
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92 86.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
2 3.6%
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0 0.0%
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2 1.9%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 55 participants | 52 participants | 107 participants |
55 100.0%
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52 100.0%
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107 100.0%
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Numeric Pain Rating Scale (NPRS) Score
[1] [2] Mean (Standard Deviation) Unit of measure: Score on a scale |
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Number Analyzed | 54 participants | 51 participants | 105 participants | |
6.20 (1.41) | 6.53 (1.23) | 6.36 (1.33) | ||
[1]
Measure Description: Participants were instructed to select a number between 0 and 10 where 0 is no pain and 10 is the worst pain possible. The scale was completed by telephone (an interactive voice response system [IVRS]) every evening before bedtime. In order to qualify for study entry, participants must have had an average score of >=4 and <10 during the baseline assessment phase.
[2]
Measure Analysis Population Description: NPRS score was calculated only on randomized participants who received at least had one dose of study treatment.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
60 days prior to the submission of any results, the PI shall submit to SPONSOR any proposed PUBLICATION, which period may be extended for an additional 30 days if requested by SPONSOR. If any Confidential Information should be redacted or patent applications relating to an Invention should be filed prior to PUBLICATION, then PUBLICATION will be delayed until patent application has been filed. Delay of a PUBLICATION shall not exceed 24 months from the date of such notice to the PI.
Results Point of Contact
Name/Title: | Senior Vice President, Global Clinical Development |
Organization: | Merck Sharp & Dohme Corp. |
Phone: | 1-800-672-6372 |
EMail: | ClinicalTrialsDisclosure@merck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Afferent Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01569438 |
Other Study ID Numbers: |
7264-005 AF219-005 ( Other Identifier: Afferent Pharmaceuticals ) MK-7264-005 ( Other Identifier: Merck Protocol Number ) |
First Submitted: | March 30, 2012 |
First Posted: | April 3, 2012 |
Results First Submitted: | September 23, 2016 |
Results First Posted: | January 12, 2017 |
Last Update Posted: | August 17, 2020 |