Efficacy of Gralise® for Chronic Pelvic Pain

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. Identifier: NCT01678911
Recruitment Status : Terminated (Study ended due to difficulties in recruitment and low enrollment.)
First Posted : September 5, 2012
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Information provided by (Responsible Party):
Dr. Norman Harden, Shirley Ryan AbilityLab

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Irritable Bowel Syndrome
Ulcerative Colitis
Interstitial Cystitis
Pelvic Pain
Intervention: Drug: Gralise

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
11 Subjects enrolled in the study and started a single-blind placebo lead-in period. Of those, 5 were randomized. 6 subjects did not continue and were either lost to follow-up, chose not to continue, or exhibited a large placebo response and no longer met the criteria to continue in the study.

Reporting Groups
Placebo, Then Gralise Subjects may receive a pill with no medicine.
Gralise Then Placebo

Gralise (a long acting gabapentinoid)

Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of “wash-out” before repeating the above procedure for the other arm of the study (placebo or medication).

Participant Flow for 2 periods

Period 1:   First Intervention
    Placebo, Then Gralise   Gralise Then Placebo
STARTED   4   1 
Cross Over   4   1 
COMPLETED   4   1 

Period 2:   Second Intervention
    Placebo, Then Gralise   Gralise Then Placebo
STARTED   4   1 
COMPLETED   2   1 
Lost to Follow-up                2                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
All Subjects All randomized subjects

Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 44.6  (13.2) 
[Units: Participants]
Female   2 
Male   3 

  Outcome Measures

1.  Primary:   McGill Pain Questionnaire - Short Form   [ Time Frame: 4 Visits over a 15 week period ]

2.  Secondary:   Pain Anxiety Symptoms Scale   [ Time Frame: 4 Visits over an 8 week period ]

3.  Secondary:   Pain Disability Index   [ Time Frame: 4 visits over an 8 week period ]

4.  Secondary:   Center for Epidemiologic Studies Depression Scale   [ Time Frame: 4 visits over 15 week period ]

5.  Secondary:   Patient Global Impression of Change   [ Time Frame: 4 Visits over 15 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was terminated early due to low recruitment. Therefore, the data presented represents a very small sample, with low 'n's in each group. The data tables represent all available data for the small sample.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.

Results Point of Contact:  
Name/Title: Director of the Center for Pain Studies
Organization: Rehabilitation Institute of Chicago
phone: 312.238.5654

Responsible Party: Dr. Norman Harden, Shirley Ryan AbilityLab Identifier: NCT01678911     History of Changes
Other Study ID Numbers: RIC_Dep_CPP_2012
First Submitted: August 31, 2012
First Posted: September 5, 2012
Results First Submitted: May 20, 2015
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015