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NCT01553318 · ClinicalTrials.gov registry record · Phase 3
Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study
A Phase 3 study of Fibromyalgia, sponsored by Indiana University.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT01553318: Completed Phase 3 study of Fibromyalgia, sponsored by Indiana University.
NCT01553318 is a Phase 3 study of Fibromyalgia that has completed, run by Indiana University. The registered enrollment target is 51 participants, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01553318, a Phase 3 study of Fibromyalgia, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this 10-week study is to determine the effects of a medication called Ketotifen on pain sensitivity; and fibromyalgia-related pain. Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that are known to cause inflammation. It is an antihistamine that reduces the harmful effects of histamine. The ophthalmic (eye drops) formulation of ketotifen has been approved by the Food and Drug Administration (FDA) and has been available in the United States for more than a decade. Oral (taken by mouth) ketotifen has been in available in other countries for several decades. Commonly prescribed for the maintenance treatment of asthma and allergic rhinitis, ketotifen has long track record of safety. To date, the oral form of ketotifen has not been approved by the FDA, therefore this study is referred to as an "investigational drug study." Prior to opening recruitment an "investigational new drug" (IND) application which included scientific data and information regarding human safety plans was submitted to and approved by the FDA.
Primary Outcome
Change in weekly average pain score from baseline to week 10 (range from -10 to +10): interpretation= the more negative the value is, the larger reduction in pain severity at week 10 is
Conditions Studied
Interventions
- DRUG Ketotifen
- DRUG Placebo (Sugar Pill)
Study Locations (1)
Indiana
- IU Clincial Research Center for Pain and Fibromyalgia - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01553318 record still lists
NCT01553318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Fibromyalgia appearing as the primary indexed condition, and to 2 interventions - of which Ketotifen is the first listed.
NCT01553318 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT01553318 about?
NCT01553318 is a clinical study titled "Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study". The purpose of this 10-week study is to determine the effects of a medication called Ketotifen on pain sensitivity; and fibromyalgia-related pain. Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that are known to cause inflammation. It is an antihistamine that...
What is the current status of trial NCT01553318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2012-03. Estimated completion is 2012-12.
What conditions does trial NCT01553318 study?
This clinical trial studies the following conditions: Fibromyalgia.
What interventions are being tested in trial NCT01553318?
The interventions under investigation include: Ketotifen (DRUG), Placebo (Sugar Pill) (DRUG).
Who is sponsoring clinical trial NCT01553318?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01553318 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fibromyalgia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01553318's enrollment target sits among peer trials
51 48th of 76 higher than 29 of 76 other Fibromyalgia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fibromyalgia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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